IES: Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00038467
Collaborator
International Collaborative Cancer Group (Other)
4,740
380
2
180.9
12.5
0.1
Study Details
Study Description
Brief Summary
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4740 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
Study Start Date
:
Feb 1, 1998
Actual Primary Completion Date
:
Jun 1, 2003
Actual Study Completion Date
:
Mar 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: B
|
Drug: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
|
| Experimental: A
|
Drug: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
|
Outcome Measures
Primary Outcome Measures
- Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study [Baseline up to Month 36]
DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
Secondary Outcome Measures
- Overall Survival (OS) at Month 36 Post-Randomization: Main Study [Baseline up to Month 120]
OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.
- Number of Events of Second Breast Cancer in Contralateral Breast: Main Study [Baseline up to Month 120]
Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.
- Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study [Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment]
BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study [Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment]
BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study [Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment]
BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment]
Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment]
C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment]
Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.
- Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment]
Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment]
N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Number of Participants With Fracture: Bone Metabolism Sub-study [Baseline up to 24 months post-treatment]
- Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
- Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization]
The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Number of Participants With Severe Endocrine Symptoms: QoL Sub-study [Baseline up to 24 months after randomization]
Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.
- Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study [6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment]
Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Endometrial Thickness: Endometrial Sub-study [Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment]
Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Uterine and Overall Ovary Volume: Endometrial Sub-study [6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment]
Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
- Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study [6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment]
Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.
- Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study [Baseline up to 24 months post-treatment]
Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.
- Number of Participants With Histological Findings: Endometrial Sub-study [Baseline up to 24 months post-treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease
Exclusion Criteria:
-
unresectable breast cancer
-
ER negative primary tumor
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35205 |
| 2 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35213 |
| 3 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35235 |
| 4 | Pfizer Investigational Site | Green Valley | Arizona | United States | 85614 |
| 5 | Pfizer Investigational Site | Green Velley | Arizona | United States | 85614 |
| 6 | Pfizer Investigational Site | Tucson | Arizona | United States | 85704 |
| 7 | Pfizer Investigational Site | Tucson | Arizona | United States | 85710 |
| 8 | Pfizer Investigational Site | Tucson | Arizona | United States | 85712 |
| 9 | Pfizer Investigational Site | Tucson | Arizona | United States | 85715 |
| 10 | Pfizer Investigational Site | Tucson | Arizona | United States | 85745 |
| 11 | Pfizer Investigational Site | Boulder | Colorado | United States | 80304 |
| 12 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80909 |
| 13 | Pfizer Investigational Site | Denver | Colorado | United States | 80218 |
| 14 | Pfizer Investigational Site | Fort Collins | Colorado | United States | 80528 |
| 15 | Pfizer Investigational Site | Lakewood | Colorado | United States | 80228 |
| 16 | Pfizer Investigational Site | Thornton | Colorado | United States | 80260 |
| 17 | Pfizer Investigational Site | Jacksonville Beach | Florida | United States | 32250 |
| 18 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32204 |
| 19 | Pfizer Investigational Site | Jacksonville | Florida | United States | 32207 |
| 20 | Pfizer Investigational Site | Ocala | Florida | United States | 34474 |
| 21 | Pfizer Investigational Site | Orange Park | Florida | United States | 32073 |
| 22 | Pfizer Investigational Site | Fishers | Indiana | United States | 46037 |
| 23 | Pfizer Investigational Site | Fishers | Indiana | United States | 46038 |
| 24 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46219 |
| 25 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46227 |
| 26 | Pfizer Investigational Site | Indianapolis | Indiana | United States | IN 46219 |
| 27 | Pfizer Investigational Site | Cedar Rapids | Iowa | United States | 52403 |
| 28 | Pfizer Investigational Site | Pittsfield | Massachusetts | United States | 01201 |
| 29 | Pfizer Investigational Site | Albany | New York | United States | 12206 |
| 30 | Pfizer Investigational Site | Latham | New York | United States | 12110-0610 |
| 31 | Pfizer Investigational Site | Portland | Oregon | United States | 97225 |
| 32 | Pfizer Investigational Site | Portland | Oregon | United States | 97227 |
| 33 | Pfizer Investigational Site | Arlington | Texas | United States | 76014-2084 |
| 34 | Pfizer Investigational Site | Bedford | Texas | United States | 76022 |
| 35 | Pfizer Investigational Site | Dallas | Texas | United States | 75230-2510 |
| 36 | Pfizer Investigational Site | Dallas | Texas | United States | 75231 |
| 37 | Pfizer Investigational Site | Dallas | Texas | United States | 75246 |
| 38 | Pfizer Investigational Site | El Paso | Texas | United States | 79902 |
| 39 | Pfizer Investigational Site | El Paso | Texas | United States | 79915 |
| 40 | Pfizer Investigational Site | Garland | Texas | United States | 75042 |
| 41 | Pfizer Investigational Site | Houston | Texas | United States | 77024 |
| 42 | Pfizer Investigational Site | Houston | Texas | United States | 77029 |
| 43 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 44 | Pfizer Investigational Site | Houston | Texas | United States | 77074 |
| 45 | Pfizer Investigational Site | Longview | Texas | United States | 75601 |
| 46 | Pfizer Investigational Site | McAllen | Texas | United States | 78503 |
| 47 | Pfizer Investigational Site | Mesquite | Texas | United States | 75150 |
| 48 | Pfizer Investigational Site | Odessa | Texas | United States | 79761 |
| 49 | Pfizer Investigational Site | Pasadena | Texas | United States | 77502 |
| 50 | Pfizer Investigational Site | Plano | Texas | United States | 75075-7787 |
| 51 | Pfizer Investigational Site | San Antonio | Texas | United States | 78217 |
| 52 | Pfizer Investigational Site | Sherman | Texas | United States | 75090 |
| 53 | Pfizer Investigational Site | Sugar Land | Texas | United States | 77479 |
| 54 | Pfizer Investigational Site | Tyler | Texas | United States | 75702 |
| 55 | Pfizer Investigational Site | Weslaco | Texas | United States | 78596 |
| 56 | Pfizer Investigational Site | Spokane | Washington | United States | 99202 |
| 57 | Pfizer Investigational Site | Spokane | Washington | United States | 99218 |
| 58 | Pfizer Investigational Site | Haedo | Buenos Aires | Argentina | 1706 |
| 59 | Pfizer Investigational Site | San Isidro | Buenos Aires | Argentina | 1642 |
| 60 | Pfizer Investigational Site | San Martin | Buenos Aires | Argentina | 1650 |
| 61 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1406 |
| 62 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1417 |
| 63 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1425 |
| 64 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1426 |
| 65 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | |
| 66 | Pfizer Investigational Site | Rosario 2000 | Pcia. de Santa Fe | Argentina | |
| 67 | Pfizer Investigational Site | Rosario | Santa Fe | Argentina | 2000 |
| 68 | Pfizer Investigational Site | Buenos Aires | Argentina | 1181 | |
| 69 | Pfizer Investigational Site | Cordoba | Argentina | X5000AA1 | |
| 70 | Pfizer Investigational Site | Camperdown | New South Wales | Australia | 2050 |
| 71 | Pfizer Investigational Site | Dubbo | New South Wales | Australia | 2830 |
| 72 | Pfizer Investigational Site | Liverpool | New South Wales | Australia | 2170 |
| 73 | Pfizer Investigational Site | Waratah | New South Wales | Australia | 2298 |
| 74 | Pfizer Investigational Site | Adelaide | South Australia | Australia | 5000 |
| 75 | Pfizer Investigational Site | Bendigo | Victoria | Australia | 3552 |
| 76 | Pfizer Investigational Site | Box Hill | Victoria | Australia | 3128 |
| 77 | Pfizer Investigational Site | Ringwood East | Victoria | Australia | 3135 |
| 78 | Pfizer Investigational Site | Antwerpen | Belgium | 2020 | |
| 79 | Pfizer Investigational Site | Arlon | Belgium | 6700 | |
| 80 | Pfizer Investigational Site | Baudour | Belgium | 7331 | |
| 81 | Pfizer Investigational Site | Brasschaat | Belgium | 2930 | |
| 82 | Pfizer Investigational Site | Bruxelles | Belgium | 1000 | |
| 83 | Pfizer Investigational Site | Bruxelles | Belgium | 1180 | |
| 84 | Pfizer Investigational Site | Charleroi | Belgium | 6000 | |
| 85 | Pfizer Investigational Site | Edegem | Belgium | 2650 | |
| 86 | Pfizer Investigational Site | Genk | Belgium | 3600 | |
| 87 | Pfizer Investigational Site | Haine St. Paul | Belgium | 7100 | |
| 88 | Pfizer Investigational Site | Hasselt | Belgium | 3500 | |
| 89 | Pfizer Investigational Site | Kraainem | Belgium | 1950 | |
| 90 | Pfizer Investigational Site | La Louviere | Belgium | 7100 | |
| 91 | Pfizer Investigational Site | Leuven | Belgium | 3000 | |
| 92 | Pfizer Investigational Site | Liege | Belgium | 4000 | |
| 93 | Pfizer Investigational Site | Merksem | Belgium | 2170 | |
| 94 | Pfizer Investigational Site | Namur | Belgium | 5000 | |
| 95 | Pfizer Investigational Site | Verviers | Belgium | 4800 | |
| 96 | Pfizer Investigational Site | Wilrijk | Belgium | 2610 | |
| 97 | Pfizer Investigational Site | Sarajevo | Bosnia and Herzegovina | 71000 | |
| 98 | Pfizer Investigational Site | Plovdiv | Bulgaria | 4004 | |
| 99 | Pfizer Investigational Site | Sofia | Bulgaria | 1504 | |
| 100 | Pfizer Investigational Site | Sofia | Bulgaria | 1756 | |
| 101 | Pfizer Investigational Site | Sofia | Bulgaria | 1784 | |
| 102 | Pfizer Investigational Site | Stara Zagora | Bulgaria | 6003 | |
| 103 | Pfizer Investigational Site | Osijek | Croatia | ||
| 104 | Pfizer Investigational Site | Split | Croatia | ||
| 105 | Pfizer Investigational Site | Zagreb | Croatia | 10000 | |
| 106 | Pfizer Investigational Site | Zagreb | Croatia | ||
| 107 | Pfizer Investigational Site | Brno | Czech Republic | 656 53 | |
| 108 | Pfizer Investigational Site | Ceske Budejovice | Czech Republic | 370 87 | |
| 109 | Pfizer Investigational Site | Prague 2 | Czech Republic | 12808 | |
| 110 | Pfizer Investigational Site | Aarhus C | Denmark | 8000 | |
| 111 | Pfizer Investigational Site | Esbjerg | Denmark | 6700 | |
| 112 | Pfizer Investigational Site | Herlev | Denmark | 2730 | |
| 113 | Pfizer Investigational Site | Herning | Denmark | 7400 | |
| 114 | Pfizer Investigational Site | Hilleroed | Denmark | 3400 | |
| 115 | Pfizer Investigational Site | Koebenhavn OE | Denmark | 2100 | |
| 116 | Pfizer Investigational Site | Naestved | Denmark | 4700 | |
| 117 | Pfizer Investigational Site | Roskilde | Denmark | 4000 | |
| 118 | Pfizer Investigational Site | Vejle | Denmark | 7100 | |
| 119 | Pfizer Investigational Site | Viborg | Denmark | 8800 | |
| 120 | Pfizer Investigational Site | Cairo | Egypt | ||
| 121 | Pfizer Investigational Site | Tartu | Estonia | 51014 | |
| 122 | Pfizer Investigational Site | Angers | France | 49033 Cedex 01 | |
| 123 | Pfizer Investigational Site | Annecy Cedex | France | 74011 | |
| 124 | Pfizer Investigational Site | Avignon Cedex 2 | France | 84082 | |
| 125 | Pfizer Investigational Site | Bordeaux | France | 33030 Cedex | |
| 126 | Pfizer Investigational Site | Bordeaux | France | 33300 Cedex | |
| 127 | Pfizer Investigational Site | Brest | France | 29609 Cedex | |
| 128 | Pfizer Investigational Site | Caen Cedex 05 | France | 14076 | |
| 129 | Pfizer Investigational Site | Caen | France | 14052 Cedex | |
| 130 | Pfizer Investigational Site | Clermont Ferrand | France | 63011 | |
| 131 | Pfizer Investigational Site | Evreux | France | 27000 | |
| 132 | Pfizer Investigational Site | Lagny Sur Marne | France | 77405 Cedex | |
| 133 | Pfizer Investigational Site | Le Havre | France | 76600 | |
| 134 | Pfizer Investigational Site | Le Mans | France | 72000 | |
| 135 | Pfizer Investigational Site | Lille | France | 59020 Cedex | |
| 136 | Pfizer Investigational Site | Lyon | France | 69373 | |
| 137 | Pfizer Investigational Site | Marseille | France | 13273 | |
| 138 | Pfizer Investigational Site | Meaux | France | 77100 | |
| 139 | Pfizer Investigational Site | Montbeliard | France | 25209 Cedex | |
| 140 | Pfizer Investigational Site | Mulhouse | France | 68070 Cedex | |
| 141 | Pfizer Investigational Site | Nice | France | 06189 | |
| 142 | Pfizer Investigational Site | Paris | France | 75248 Cedex 5 | |
| 143 | Pfizer Investigational Site | Paris | France | 75970 Cedex 20 | |
| 144 | Pfizer Investigational Site | Perpignan | France | 66046 | |
| 145 | Pfizer Investigational Site | Rennes | France | 35042 | |
| 146 | Pfizer Investigational Site | Rouen | France | 76038 Cedex | |
| 147 | Pfizer Investigational Site | Saint-Herblain | France | 44805 | |
| 148 | Pfizer Investigational Site | St Cloud | France | 92210 | |
| 149 | Pfizer Investigational Site | Strasbourg | France | 67091 Cedex | |
| 150 | Pfizer Investigational Site | Toulouse | France | 31502 | |
| 151 | Pfizer Investigational Site | Berlin | Germany | 10117 | |
| 152 | Pfizer Investigational Site | Berlin | Germany | 13353 | |
| 153 | Pfizer Investigational Site | Chemnitz | Germany | 09126 | |
| 154 | Pfizer Investigational Site | Erlangen | Germany | 91054 | |
| 155 | Pfizer Investigational Site | Freiburg | Germany | 79106 | |
| 156 | Pfizer Investigational Site | Gera | Germany | 07548 | |
| 157 | Pfizer Investigational Site | Greiz | Germany | 07973 | |
| 158 | Pfizer Investigational Site | Halle | Germany | 06110 | |
| 159 | Pfizer Investigational Site | Halle | Germany | 06120 | |
| 160 | Pfizer Investigational Site | Hamburg | Germany | 22081 | |
| 161 | Pfizer Investigational Site | Hildburghausen | Germany | 98646 | |
| 162 | Pfizer Investigational Site | Leipzig | Germany | 04129 | |
| 163 | Pfizer Investigational Site | Luebeck | Germany | 23538 | |
| 164 | Pfizer Investigational Site | Muenchen | Germany | 80335 | |
| 165 | Pfizer Investigational Site | Riesa | Germany | 01589 | |
| 166 | Pfizer Investigational Site | Rodewisch | Germany | 08228 | |
| 167 | Pfizer Investigational Site | Saarbruecken | Germany | 66113 | |
| 168 | Pfizer Investigational Site | Suhl | Germany | 98527 | |
| 169 | Pfizer Investigational Site | Weiden | Germany | 92637 | |
| 170 | Pfizer Investigational Site | Athens | Attiki | Greece | 115 22 |
| 171 | Pfizer Investigational Site | Athens | Attiki | Greece | 115 28 |
| 172 | Pfizer Investigational Site | Heraklion | Crete | Greece | 71 110 |
| 173 | Pfizer Investigational Site | New Territories | Hong Kong | ||
| 174 | Pfizer Investigational Site | Budapest | Hungary | 1082 | |
| 175 | Pfizer Investigational Site | Budapest | Hungary | 1122 | |
| 176 | Pfizer Investigational Site | Budapest | Hungary | 1145 | |
| 177 | Pfizer Investigational Site | Cork, Ireland | Ireland | ||
| 178 | Pfizer Investigational Site | Cork | Ireland | ||
| 179 | Pfizer Investigational Site | Dublin 9 | Ireland | ||
| 180 | Pfizer Investigational Site | Dublin | Ireland | ||
| 181 | Pfizer Investigational Site | Galway | Ireland | ||
| 182 | Pfizer Investigational Site | Haifa | Israel | 34362 | |
| 183 | Pfizer Investigational Site | Haifa | Israel | ||
| 184 | Pfizer Investigational Site | Jerusalem | Israel | 91120 | |
| 185 | Pfizer Investigational Site | Jerusalem | Israel | ||
| 186 | Pfizer Investigational Site | Kfar Saba | Israel | ||
| 187 | Pfizer Investigational Site | Petah Tikva | Israel | ||
| 188 | Pfizer Investigational Site | Rehovot | Israel | ||
| 189 | Pfizer Investigational Site | Carpi | Modena | Italy | 41012 |
| 190 | Pfizer Investigational Site | Alba (CN) | Italy | 12051 | |
| 191 | Pfizer Investigational Site | Aviano (PN) | Italy | 33081 | |
| 192 | Pfizer Investigational Site | Bergamo | Italy | 24128 | |
| 193 | Pfizer Investigational Site | Biella | Italy | 13900 | |
| 194 | Pfizer Investigational Site | Cagliari | Italy | 09121 | |
| 195 | Pfizer Investigational Site | Casale Monferrato, AL | Italy | 15033 | |
| 196 | Pfizer Investigational Site | Correggio | Italy | 42015 | |
| 197 | Pfizer Investigational Site | Cremona | Italy | 26100 | |
| 198 | Pfizer Investigational Site | Cuneo | Italy | 12100 | |
| 199 | Pfizer Investigational Site | Fermo FM | Italy | 63023 | |
| 200 | Pfizer Investigational Site | Firenze | Italy | 50134 | |
| 201 | Pfizer Investigational Site | Genova | Italy | 16128 | |
| 202 | Pfizer Investigational Site | Genova | Italy | 16132 | |
| 203 | Pfizer Investigational Site | Lecco | Italy | 23900 | |
| 204 | Pfizer Investigational Site | Lodi | Italy | 20075 | |
| 205 | Pfizer Investigational Site | Mantova | Italy | 46100 | |
| 206 | Pfizer Investigational Site | Milano | Italy | 20121 | |
| 207 | Pfizer Investigational Site | Milano | Italy | 20133 | |
| 208 | Pfizer Investigational Site | Milano | Italy | 20141 | |
| 209 | Pfizer Investigational Site | Milano | Italy | 21053 | |
| 210 | Pfizer Investigational Site | Modena | Italy | 41100 | |
| 211 | Pfizer Investigational Site | Monserrato (CA) | Italy | 09042 | |
| 212 | Pfizer Investigational Site | Monza | Italy | 20052 | |
| 213 | Pfizer Investigational Site | Napoli | Italy | 80131 | |
| 214 | Pfizer Investigational Site | Palermo | Italy | 90139 | |
| 215 | Pfizer Investigational Site | Parma | Italy | 43100 | |
| 216 | Pfizer Investigational Site | Perugia | Italy | 06132 | |
| 217 | Pfizer Investigational Site | Piacenza | Italy | 29100 | |
| 218 | Pfizer Investigational Site | Pietra Ligure (SV) | Italy | 17027 | |
| 219 | Pfizer Investigational Site | Pisa | Italy | 56100 | |
| 220 | Pfizer Investigational Site | Reggio Emilia | Italy | 42100 | |
| 221 | Pfizer Investigational Site | Roma | Italy | 00148 | |
| 222 | Pfizer Investigational Site | Sassari | Italy | 07100 | |
| 223 | Pfizer Investigational Site | Terni | Italy | 05100 | |
| 224 | Pfizer Investigational Site | Thiene (VI) | Italy | 36016 | |
| 225 | Pfizer Investigational Site | Torino | Italy | 10126 | |
| 226 | Pfizer Investigational Site | Tortona | Italy | 15057 | |
| 227 | Pfizer Investigational Site | Trescore Balneario BG | Italy | 24069 | |
| 228 | Pfizer Investigational Site | Treviglio (BG) | Italy | 24047 | |
| 229 | Pfizer Investigational Site | Varese | Italy | 21100 | |
| 230 | Pfizer Investigational Site | Luxembourg | Luxembourg | 1210 | |
| 231 | Pfizer Investigational Site | Floriana | Malta | VLT 14 | |
| 232 | Pfizer Investigational Site | Amersfoort | Netherlands | 3818 ES | |
| 233 | Pfizer Investigational Site | Amsterdam | Netherlands | 1061 AE | |
| 234 | Pfizer Investigational Site | Amsterdam | Netherlands | 1066 CX | |
| 235 | Pfizer Investigational Site | Amsterdam | Netherlands | 1105 AZ | |
| 236 | Pfizer Investigational Site | Apeldoorn | Netherlands | 7300 DS | |
| 237 | Pfizer Investigational Site | Blaricum | Netherlands | 1261 AN | |
| 238 | Pfizer Investigational Site | Breda | Netherlands | 4818 CK | |
| 239 | Pfizer Investigational Site | Delft | Netherlands | 2625 AD | |
| 240 | Pfizer Investigational Site | Den Haag | Netherlands | 2545 CH | |
| 241 | Pfizer Investigational Site | Eindhoven | Netherlands | 5623 EJ | |
| 242 | Pfizer Investigational Site | Enschede | Netherlands | 7513 ER | |
| 243 | Pfizer Investigational Site | Groningen | Netherlands | 9700 RM | |
| 244 | Pfizer Investigational Site | Groningen | Netherlands | 9728 NZ | |
| 245 | Pfizer Investigational Site | Hengelo | Netherlands | 7555 DL | |
| 246 | Pfizer Investigational Site | Leeuwarden | Netherlands | 8934 AD | |
| 247 | Pfizer Investigational Site | Leiden | Netherlands | 2333 ZA | |
| 248 | Pfizer Investigational Site | Leidschendam | Netherlands | 2262 BA | |
| 249 | Pfizer Investigational Site | Podybus 90153 | Netherlands | 5200 ME Den Bosch | |
| 250 | Pfizer Investigational Site | Roermond | Netherlands | 6043 CV | |
| 251 | Pfizer Investigational Site | Sittard | Netherlands | 6131 BK | |
| 252 | Pfizer Investigational Site | Utrecht | Netherlands | 3582 KE | |
| 253 | Pfizer Investigational Site | Veldhoven | Netherlands | 5504 DB | |
| 254 | Pfizer Investigational Site | Zaandam | Netherlands | 1502 DV | |
| 255 | Pfizer Investigational Site | Hamilton | Waikato | New Zealand | 2021 |
| 256 | Pfizer Investigational Site | Auckland | New Zealand | 1142 | |
| 257 | Pfizer Investigational Site | Bergen | Norway | 5021 | |
| 258 | Pfizer Investigational Site | Bodo | Norway | 8092 | |
| 259 | Pfizer Investigational Site | Fredrikstad | Norway | 1603 | |
| 260 | Pfizer Investigational Site | Haugesund | Norway | 5390 | |
| 261 | Pfizer Investigational Site | Levanger | Norway | 7600 | |
| 262 | Pfizer Investigational Site | Mo i Rana | Norway | 8607 | |
| 263 | Pfizer Investigational Site | Molde | Norway | 6407 | |
| 264 | Pfizer Investigational Site | Notodden | Norway | 3674 | |
| 265 | Pfizer Investigational Site | Oslo | Norway | ||
| 266 | Pfizer Investigational Site | Rissa | Norway | 7100 | |
| 267 | Pfizer Investigational Site | Rjukan | Norway | 3660 | |
| 268 | Pfizer Investigational Site | Sandefjord | Norway | ||
| 269 | Pfizer Investigational Site | Tonsberg | Norway | 3103 | |
| 270 | Pfizer Investigational Site | Tromso | Norway | 9038 | |
| 271 | Pfizer Investigational Site | Tromsø | Norway | 9038 | |
| 272 | Pfizer Investigational Site | Lima | Peru | L34 | |
| 273 | Pfizer Investigational Site | Gdansk | Poland | 80-952 | |
| 274 | Pfizer Investigational Site | Gliwice | Poland | 44-101 | |
| 275 | Pfizer Investigational Site | Krakow | Poland | 31-115 | |
| 276 | Pfizer Investigational Site | Krakow | Poland | 31-826 | |
| 277 | Pfizer Investigational Site | Lodz | Poland | 93-509 | |
| 278 | Pfizer Investigational Site | Opole | Poland | 45-060 | |
| 279 | Pfizer Investigational Site | Poznan | Poland | 61-878 | |
| 280 | Pfizer Investigational Site | Sopot | Poland | 81-756 | |
| 281 | Pfizer Investigational Site | Warszawa | Poland | 02-781 | |
| 282 | Pfizer Investigational Site | Coimbra | Portugal | 3040 | |
| 283 | Pfizer Investigational Site | Coimbra | Portugal | ||
| 284 | Pfizer Investigational Site | Evora | Portugal | 7000-811 | |
| 285 | Pfizer Investigational Site | Bucuresti | Romania | 72435 | |
| 286 | Pfizer Investigational Site | Cluj Napoca | Romania | 400015 | |
| 287 | Pfizer Investigational Site | Timisoara | Romania | 300223 | |
| 288 | Pfizer Investigational Site | St. Petersburg | Russian Federation | 197758 | |
| 289 | Pfizer Investigational Site | Belgrade | Serbia | 11000 | |
| 290 | Pfizer Investigational Site | Sremska Kamenica | Serbia | 21204 | |
| 291 | Pfizer Investigational Site | Banska Bystrica | Slovakia | 97517 | |
| 292 | Pfizer Investigational Site | Bratislava | Slovakia | SK-83310 | |
| 293 | Pfizer Investigational Site | Kosice | Slovakia | 041 90 | |
| 294 | Pfizer Investigational Site | Ljubljana | Slovenia | 1000 | |
| 295 | Pfizer Investigational Site | Johannesburg | Gauteng | South Africa | 2196 |
| 296 | Pfizer Investigational Site | Observatory | South Africa | 7925 | |
| 297 | Pfizer Investigational Site | Alcoy | Alicante | Spain | 03804 |
| 298 | Pfizer Investigational Site | Elche | Alicante | Spain | 03203 |
| 299 | Pfizer Investigational Site | San Juan de Alicante | Alicante | Spain | 03550 |
| 300 | Pfizer Investigational Site | Sant Joan D'Alacant | Alicante | Spain | 03550 |
| 301 | Pfizer Investigational Site | Badalona | Barcelona | Spain | 08911 |
| 302 | Pfizer Investigational Site | Badalona | Barcelona | Spain | 08916 |
| 303 | Pfizer Investigational Site | Terrassa | Barcelona | Spain | 08221 |
| 304 | Pfizer Investigational Site | Terrassa | Barcelona | Spain | 08227 |
| 305 | Pfizer Investigational Site | San Sebastian | Guipuzcoa | Spain | 20014 |
| 306 | Pfizer Investigational Site | Barbastro | Huesca | Spain | 22300 |
| 307 | Pfizer Investigational Site | Reus | Tarragona | Spain | 43201 |
| 308 | Pfizer Investigational Site | Albacete | Spain | 02006 | |
| 309 | Pfizer Investigational Site | Alicante | Spain | 03010 | |
| 310 | Pfizer Investigational Site | Badajoz | Spain | 06008 | |
| 311 | Pfizer Investigational Site | Badajoz | Spain | 06080 | |
| 312 | Pfizer Investigational Site | Cordoba | Spain | 14004 | |
| 313 | Pfizer Investigational Site | Guadalajara | Spain | 19002 | |
| 314 | Pfizer Investigational Site | Lleida | Spain | 25198 | |
| 315 | Pfizer Investigational Site | Madrid | Spain | 28034 | |
| 316 | Pfizer Investigational Site | Madrid | Spain | 28040 | |
| 317 | Pfizer Investigational Site | Madrid | Spain | 28041 | |
| 318 | Pfizer Investigational Site | Valencia | Spain | 46014 | |
| 319 | Pfizer Investigational Site | Zaragoza | Spain | 50009 | |
| 320 | Pfizer Investigational Site | Boras | Sweden | 501 82 | |
| 321 | Pfizer Investigational Site | Borås | Sweden | 50182 | |
| 322 | Pfizer Investigational Site | Goteborg | Sweden | 413 45 | |
| 323 | Pfizer Investigational Site | Halmstad | Sweden | 301 85 | |
| 324 | Pfizer Investigational Site | Helsingborg | Sweden | 251 87 | |
| 325 | Pfizer Investigational Site | Kristianstad | Sweden | 291 85 | |
| 326 | Pfizer Investigational Site | Linkoping | Sweden | 581 85 | |
| 327 | Pfizer Investigational Site | Lund | Sweden | 221 85 | |
| 328 | Pfizer Investigational Site | Malmo | Sweden | 205 02 | |
| 329 | Pfizer Investigational Site | Motala | Sweden | 591 85 | |
| 330 | Pfizer Investigational Site | Norrkoping | Sweden | 601 82 | |
| 331 | Pfizer Investigational Site | Nässjö | Sweden | 575 81 | |
| 332 | Pfizer Investigational Site | Varnamo | Sweden | 331 85 | |
| 333 | Pfizer Investigational Site | Vasteras | Sweden | 721 89 | |
| 334 | Pfizer Investigational Site | Vastervik | Sweden | 59381 | |
| 335 | Pfizer Investigational Site | Vaxjo | Sweden | 351 85 | |
| 336 | Pfizer Investigational Site | Basel | Switzerland | CH-4031 | |
| 337 | Pfizer Investigational Site | Bellinzona | Switzerland | CH-6500 | |
| 338 | Pfizer Investigational Site | Bern | Switzerland | 3010 | |
| 339 | Pfizer Investigational Site | Bern | Switzerland | CH-3012 | |
| 340 | Pfizer Investigational Site | Genève | Switzerland | CH-1211 | |
| 341 | Pfizer Investigational Site | Huntingdon | Cambs | United Kingdom | PE18 8NT |
| 342 | Pfizer Investigational Site | Bournemouth | Dorset | United Kingdom | BH7 7DW |
| 343 | Pfizer Investigational Site | Hull | East Yorkshire | United Kingdom | HU16 5JQ |
| 344 | Pfizer Investigational Site | Epping | Essex | United Kingdom | CM166TN |
| 345 | Pfizer Investigational Site | Westcliff-On-Sea | Essex | United Kingdom | SS0 0RY |
| 346 | Pfizer Investigational Site | Newport | Gwent | United Kingdom | NP6 2UB |
| 347 | Pfizer Investigational Site | Bangor | Gwynedd | United Kingdom | LL57 2PW |
| 348 | Pfizer Investigational Site | Salterhebble | Halifax | United Kingdom | HX6 0PW |
| 349 | Pfizer Investigational Site | Gosport | Hants | United Kingdom | PO12 2AA |
| 350 | Pfizer Investigational Site | Northwood | Middlesex | United Kingdom | HA6 2RN |
| 351 | Pfizer Investigational Site | Londonderry | N. Ireland | United Kingdom | BT47 1SB |
| 352 | Pfizer Investigational Site | Harrogate | N. Yorkshire | United Kingdom | HG2 7SX |
| 353 | Pfizer Investigational Site | Taunton | Somerset | United Kingdom | TA1 5DA |
| 354 | Pfizer Investigational Site | Swansea | South Wales | United Kingdom | SA2 8QA |
| 355 | Pfizer Investigational Site | York | Yorkshire | United Kingdom | Y03 7He |
| 356 | Pfizer Investigational Site | Belfast | United Kingdom | BT97AB | |
| 357 | Pfizer Investigational Site | Bradford | United Kingdom | BD9 6RJ | |
| 358 | Pfizer Investigational Site | Bristol | United Kingdom | BS10 5NB | |
| 359 | Pfizer Investigational Site | Cardiff | United Kingdom | CF14 2TL | |
| 360 | Pfizer Investigational Site | Coventry | United Kingdom | CV2 2DX | |
| 361 | Pfizer Investigational Site | East Kilbride | United Kingdom | G75 8RG | |
| 362 | Pfizer Investigational Site | Huddersfield | United Kingdom | HD3 3EA | |
| 363 | Pfizer Investigational Site | Leeds | United Kingdom | LS1 3EX | |
| 364 | Pfizer Investigational Site | Leeds | United Kingdom | LS9 7TF | |
| 365 | Pfizer Investigational Site | Lincoln | United Kingdom | ||
| 366 | Pfizer Investigational Site | London | United Kingdom | N18 1QX | |
| 367 | Pfizer Investigational Site | London | United Kingdom | N19 5NF | |
| 368 | Pfizer Investigational Site | London | United Kingdom | NW3 2QG | |
| 369 | Pfizer Investigational Site | London | United Kingdom | SW17 0QT | |
| 370 | Pfizer Investigational Site | London | United Kingdom | W6 8RF | |
| 371 | Pfizer Investigational Site | Luton | United Kingdom | LU4 0DZ | |
| 372 | Pfizer Investigational Site | Manchester | United Kingdom | M20 4BX | |
| 373 | Pfizer Investigational Site | Sheffield | United Kingdom | S10 2SJ | |
| 374 | Pfizer Investigational Site | Shrewsbury | United Kingdom | ||
| 375 | Pfizer Investigational Site | Somerset | United Kingdom | BA21 4AT | |
| 376 | Pfizer Investigational Site | Southampton | United Kingdom | S016 6YD | |
| 377 | Pfizer Investigational Site | Steeton | United Kingdom | BD20 6TD | |
| 378 | Pfizer Investigational Site | Stoke on Trent | United Kingdom | ST4 6QG | |
| 379 | Pfizer Investigational Site | Telford | United Kingdom | TF1 6TF | |
| 380 | Pfizer Investigational Site | Wythenshawe, Manchester | United Kingdom | M23 9LT |
Sponsors and Collaborators
- Pfizer
- International Collaborative Cancer Group
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00038467
Other Study ID Numbers:
- 96-OEXE-031
- A5991012
First Posted:
Jun 3, 2002
Last Update Posted:
May 7, 2014
Last Verified:
Apr 1, 2014
Study Results
Participant Flow
| Recruitment Details | The publication describing study results (Coombes RC et al; N Engl J Med 350; 1119) stated that 4742 participants were enrolled in study. It was later discovered that 2 participants were randomized twice. Hence, 4740 participants were enrolled in this study. |
|---|---|
| Pre-assignment Detail | Main study also included 3 sub-studies only for the purpose of tolerability assessment: endometrial status, bone metabolism and quality of life (QoL). Out of 4740 enrolled participants, data for 16 participants from a center were excluded since it was considered unreliable. Results are reported for remaining 4724 participants. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Period Title: Overall Study | ||
| STARTED | 2352 | 2372 |
| Treated | 2321 | 2337 |
| COMPLETED | 1810 | 1830 |
| NOT COMPLETED | 542 | 542 |
Baseline Characteristics
| Arm/Group Title | Exemestane | Tamoxifen | Total |
|---|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. | Total of all reporting groups |
| Overall Participants | 2352 | 2372 | 4724 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.78
(8.12)
|
63.69
(8.22)
|
63.73
(8.17)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2352
100%
|
2372
100%
|
4724
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study |
|---|---|
| Description | DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ. |
| Time Frame | Baseline up to Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 2352 | 2372 |
| Number (95% Confidence Interval) [probability of DFS] |
0.90
|
0.86
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.00003 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.69 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Survival (OS) at Month 36 Post-Randomization: Main Study |
|---|---|
| Description | OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data. |
| Time Frame | Baseline up to Month 120 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 2352 | 2372 |
| Number (95% Confidence Interval) [probability of OS] |
0.953
|
0.941
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15737 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.913 | |
| Confidence Interval |
(2-Sided) 95% 0.806 to 1.036 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Events of Second Breast Cancer in Contralateral Breast: Main Study |
|---|---|
| Description | Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported. |
| Time Frame | Baseline up to Month 120 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 2352 | 2372 |
| Number [events] |
57
|
75
|
| Title | Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study |
|---|---|
| Description | BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 84 | 96 |
| Change at 6 months on-treatment: LS (n=84,96) |
-2.64
(2.89)
|
-0.22
(2.55)
|
| Change at 6 months on-treatment: TH (n=82,96) |
-1.31
(2.20)
|
-0.13
(1.90)
|
| Change at 12 months on-treatment: LS (n=82,96) |
-2.98
(3.30)
|
-0.19
(3.53)
|
| Change at 12 months on-treatment: TH (n=82,95) |
-2.17
(2.34)
|
-0.39
(2.17)
|
| Change at 24 months on-treatment: LS (n=82,92) |
-3.69
(4.12)
|
-0.47
(3.38)
|
| Change at 24 months on-treatment: TH (n=79,93) |
-2.81
(2.61)
|
-0.91
(2.66)
|
| Change at 24 months post-treatment: LS (n=74,81) |
-2.17
(5.09)
|
-3.44
(4.28)
|
| Change at 24 months post-treatment: TH (n=73,84) |
-3.06
(4.35)
|
-4.15
(4.01)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.43 | |
| Confidence Interval |
(2-Sided) 95% 1.63 to 3.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months on-treatment (total hip): p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.18 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 1.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.79 | |
| Confidence Interval |
(2-Sided) 95% 1.77 to 3.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months on-treatment (total hip): p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.79 | |
| Confidence Interval |
(2-Sided) 95% 1.12 to 2.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.22 | |
| Confidence Interval |
(2-Sided) 95% 2.10 to 4.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months on-treatment (total hip): p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.90 | |
| Confidence Interval |
(2-Sided) 95% 1.10 to 2.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study |
|---|---|
| Description | BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 82 | 95 |
| Change at 6 months on-treatment: FN (n=82,94) |
-1.91
(3.17)
|
-0.30
(3.75)
|
| Change at 6 months on-treatment: FW (n=82,94) |
-2.02
(4.57)
|
0.32
(5.53)
|
| Change at 12 months on-treatment: FN (n=82,95) |
-2.56
(3.26)
|
-0.32
(3.60)
|
| Change at 12 months on-treatment: FW (n=81,95) |
-3.51
(4.88)
|
-1.30
(5.84)
|
| Change at 24 months on-treatment: FN (n=78,89) |
-4.00
(3.61)
|
-0.78
(4.85)
|
| Change at 24 months on-treatment: FW (n=72,87) |
-4.75
(6.29)
|
-1.86
(7.32)
|
| Change at 24 months post-treatment: FN (n=61,69) |
-4.10
(5.57)
|
-4.95
(6.46)
|
| Change at 24 months post-treatment: FW (n=60,68) |
-6.07
(7.63)
|
-8.60
(8.15)
|
| Title | Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study |
|---|---|
| Description | BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 86 | 99 |
| Baseline: LS (n=86,99) |
-0.62
(1.12)
|
-0.45
(1.14)
|
| Baseline: TH (n=86,99) |
-0.27
(0.97)
|
-0.12
(1.01)
|
| Change at 6 months on-treatment: LS (n=84,96) |
-0.24
(0.26)
|
-0.02
(0.23)
|
| Change at 6 months on-treatment: TH (n=82,96) |
-0.10
(0.19)
|
-0.00
(0.16)
|
| Change at 12 months on-treatment: LS (n=82,96) |
-0.26
(0.30)
|
-0.02
(0.32)
|
| Change at 12 months on-treatment: TH (n=82,95) |
-0.16
(0.21)
|
-0.03
(0.18)
|
| Change at 24 months on-treatment: LS (n=82,92) |
-0.32
(0.41)
|
-0.04
(0.31)
|
| Change at 24 months on-treatment: TH (n=79,93) |
-0.21
(0.27)
|
-0.07
(0.24)
|
| Change at 24 months post-treatment: LS (n=74,81) |
-0.21
(0.47)
|
-0.33
(0.41)
|
| Change at 24 months post-treatment: TH (n=73,84) |
-0.25
(0.38)
|
-0.34
(0.33)
|
| Title | Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study |
|---|---|
| Description | Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 83 | 96 |
| 3 months: on-treatment (n=81, 92) |
113.47
|
104.35
|
| 6 months: on-treatment (n=83, 95) |
121.01
|
104.34
|
| 9 months: on-treatment (n=79, 92) |
139.62
|
98.17
|
| 12 months: on-treatment (n=82, 96) |
148.96
|
100.47
|
| 18 months: on-treatment (n=80, 95) |
158.33
|
102.72
|
| 24 months: on-treatment (n=81, 90) |
155.89
|
105.12
|
| 30 months: on-treatment (n=50, 65) |
144.89
|
108.33
|
| 36 months: end of treatment (n=19, 31) |
150.82
|
113.87
|
| 12 months: post-treatment (n=67, 87) |
140.19
|
149.69
|
| 24 months: post-treatment (n=62, 77) |
128.73
|
142.20
|
| Title | Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study |
|---|---|
| Description | C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 83 | 96 |
| 3 months: on-treatment (n=81, 93) |
144.14
|
99.19
|
| 6 months: on-treatment (n=83, 95) |
197.47
|
93.67
|
| 9 months: on-treatment (n=79, 92) |
226.04
|
94.40
|
| 12 months: on-treatment (n=81, 96) |
232.69
|
94.59
|
| 18 months: on-treatment (n=80, 95) |
199.68
|
90.35
|
| 24 months: on-treatment (n=81, 90) |
177.80
|
88.80
|
| 30 months: on-treatment (n=50, 65) |
179.29
|
91.62
|
| 36 months: end of treatment (n=19, 31) |
130.00
|
99.34
|
| 12 months: post-treatment (n=67, 87) |
110.87
|
136.50
|
| 24 months: post-treatment (n=62, 77) |
100.34
|
124.03
|
| Title | Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study |
|---|---|
| Description | Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 83 | 96 |
| 3 months, on-treatment: OC (n=81, 92) |
149.49
|
101.02
|
| 3 months, on-treatment: PICP (n=81, 92) |
117.23
|
102.19
|
| 6 months, on-treatment: OC (n=83, 95) |
193.44
|
97.69
|
| 6 months, on-treatment: PICP (n=83, 95) |
133.50
|
99.78
|
| 9 months, on-treatment: OC (n=79, 93) |
230.41
|
92.52
|
| 9 months, on-treatment: PICP (n=79, 92) |
131.73
|
96.52
|
| 12 months, on-treatment: OC (n=82, 96) |
227.59
|
95.75
|
| 12 months, on-treatment: PICP (n=82, 96) |
128.68
|
100.18
|
| 18 months, on-treatment: OC (n=80, 95) |
230.72
|
93.98
|
| 18 months, on-treatment: PICP (n=80, 95) |
125.40
|
103.25
|
| 24 months, on-treatment: OC (n=81, 90) |
190.18
|
89.29
|
| 24 months: on-treatment: PICP (n=81, 90) |
123.75
|
103.94
|
| 30 months, on-treatment: OC (n=50, 65) |
187.23
|
87.34
|
| 30 months, on-treatment: PICP (n=50, 65) |
113.76
|
103.36
|
| 36 months, end of treatment: OC (n=19, 30) |
167.03
|
90.77
|
| 36 months, end of treatment: PICP (n=19, 31) |
95.33
|
87.22
|
| 12 months, post-treatment: OC (n=67, 87) |
143.85
|
152.32
|
| 12 months, post-treatment: PICP (n=67, 87) |
91.53
|
108.67
|
| 24 months, post-treatment: OC (n=62, 77) |
130.78
|
146.36
|
| 24 months, post-treatment: PICP (n=62, 77) |
90.46
|
100.74
|
| Title | Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study |
|---|---|
| Description | Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 83 | 97 |
| 3 months: on-treatment (n=82, 91) |
130.49
|
106.99
|
| 6 months: on-treatment (n=83, 95) |
145.13
|
103.42
|
| 9 months: on-treatment (n=80, 92) |
160.12
|
101.08
|
| 12 months: on-treatment (n=82, 97) |
155.53
|
104.51
|
| 18 months: on-treatment (n=77, 96) |
139.57
|
99.25
|
| 24 months: on-treatment (n=78, 90) |
135.30
|
99.11
|
| 30 months: on-treatment (n=49, 63) |
121.39
|
95.97
|
| 36 months: end of treatment (n=19, 31) |
107.64
|
101.04
|
| 12 months: post-treatment (n=65, 84) |
117.94
|
128.47
|
| 24 months: post-treatment (n=61, 77) |
105.50
|
120.84
|
| Title | Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study |
|---|---|
| Description | N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 83 | 97 |
| 3 months: on-treatment (n=82, 91) |
128.35
|
101.92
|
| 6 months: on-treatment (n=83, 95) |
153.67
|
100.64
|
| 9 months: on-treatment (n=80, 92) |
168.15
|
101.44
|
| 12 months: on-treatment (n=82, 97) |
177.58
|
104.42
|
| 18 months: on-treatment (n=77, 96) |
171.46
|
98.74
|
| 24 months: on-treatment (n=78, 90) |
167.87
|
104.55
|
| 30 months: on-treatment (n=49, 63) |
168.52
|
96.51
|
| 36 months: end of treatment (n=19, 31) |
152.13
|
105.58
|
| 12 months: post-treatment (n=65, 84) |
121.00
|
158.12
|
| 24 months: post-treatment (n=61, 77) |
108.18
|
143.98
|
| Title | Number of Participants With Fracture: Bone Metabolism Sub-study |
|---|---|
| Description | |
| Time Frame | Baseline up to 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 101 | 105 |
| Number [participants] |
7
0.3%
|
10
0.4%
|
| Title | Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 251 | 251 |
| Change at 3 months (n=251, 251) |
-0.61
(7.72)
|
-0.16
(7.24)
|
| Change at 6 months (n=244, 243) |
-2.10
(9.66)
|
-0.01
(7.96)
|
| Change at 9 months (n=242, 235) |
-1.18
(8.62)
|
0.17
(8.10)
|
| Change at 12 months (n=230, 238) |
-0.40
(8.03)
|
-0.66
(8.49)
|
| Change at 18 months (n=232, 227) |
-0.95
(8.99)
|
-0.11
(8.32)
|
| Change at 24 months (n=221, 213) |
-0.57
(9.06)
|
0.54
(8.36)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.500 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% -1.76 to 0.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.10 | |
| Confidence Interval |
(2-Sided) 95% -3.67 to -0.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.079 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.35 | |
| Confidence Interval |
(2-Sided) 95% -2.86 to 0.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.729 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.27 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to 1.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.302 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.84 | |
| Confidence Interval |
(2-Sided) 95% -2.43 to 0.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.187 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.11 | |
| Confidence Interval |
(2-Sided) 95% -2.76 to 0.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 254 | 253 |
| Change at 3 months (n=254, 253) |
0.04
(6.67)
|
0.70
(6.40)
|
| Change at 6 months (n=245, 243) |
0.17
(7.26)
|
0.96
(6.54)
|
| Change at 9 months (n=243, 238) |
1.10
(6.54)
|
1.32
(6.29)
|
| Change at 12 months (n=233, 236) |
1.98
(6.72)
|
1.15
(7.08)
|
| Change at 18 months (n=235, 226) |
1.25
(7.52)
|
1.41
(6.67)
|
| Change at 24 months (n=222, 214) |
1.93
(7.26)
|
1.51
(6.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.260 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 95% -1.80 to 0.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.209 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.79 | |
| Confidence Interval |
(2-Sided) 95% -2.02 to 0.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.698 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -1.38 to 0.92 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.192 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to 2.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.813 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -1.46 to 1.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.537 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.42 | |
| Confidence Interval |
(2-Sided) 95% -0.91 to 1.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 252 | 252 |
| Change at 3 months (n=252, 252) |
-0.91
(17.41)
|
-0.38
(16.17)
|
| Change at 6 months (n=244, 243) |
-3.12
(17.84)
|
-0.04
(16.21)
|
| Change at 9 months (n=243, 236) |
-1.28
(15.09)
|
-0.38
(17.99)
|
| Change at 12 months (n=229, 236) |
0.38
(18.91)
|
-0.53
(14.71)
|
| Change at 18 months (n=232, 225) |
-0.67
(17.37)
|
0.06
(16.26)
|
| Change at 24 months (n=220, 212) |
-1.48
(22.44)
|
1.43
(16.32)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.727 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.52 | |
| Confidence Interval |
(2-Sided) 95% -3.46 to 2.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.047 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.08 | |
| Confidence Interval |
(2-Sided) 95% -6.12 to -0.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.553 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -3.88 to 2.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.563 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% -2.17 to 3.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.643 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.73 | |
| Confidence Interval |
(2-Sided) 95% -3.83 to 2.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.126 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.91 | |
| Confidence Interval |
(2-Sided) 95% -6.63 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 253 | 252 |
| Change at 3 months (n=253, 252) |
-0.32
(3.05)
|
-0.02
(2.98)
|
| Change at 6 months(n=246, 244) |
-1.08
(4.16)
|
0.13
(2.88)
|
| Change at 9 months (n=242, 237) |
-0.37
(3.16)
|
0.06
(3.16)
|
| Change at 12 months (n=233, 238) |
-0.26
(2.90)
|
-0.12
(3.30)
|
| Change at 18 months(n=234, 228) |
-0.19
(3.09)
|
0.02
(2.81)
|
| Change at 24 months (n=223, 214) |
-0.005
(0.208)
|
0.22
(0.214)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.265 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to 0.23 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.21 | |
| Confidence Interval |
(2-Sided) 95% -1.84 to -0.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.132 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.44 | |
| Confidence Interval |
(2-Sided) 95% -1.00 to 0.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.635 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.70 to 0.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.449 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to 0.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.454 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to 0.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 252 | 249 |
| Change at 3 months (n=252, 249) |
-0.25
(3.90)
|
-0.37
(3.59)
|
| Change at 6 months (n=245, 241) |
-0.43
(3.84)
|
-0.47
(4.01)
|
| Change at 9 months (n=242, 235) |
-0.58
(3.61)
|
-0.53
(4.22)
|
| Change at 12 months (n=231, 235) |
0.05
(4.03)
|
-0.56
(3.87)
|
| Change at 18 months(n=234, 226) |
-0.5
(3.62)
|
-0.69
(4.31)
|
| Change at 24 months (n=219, 212) |
-0.99
(4.96)
|
-0.72
(4.44)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.712 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 0.335 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.899 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to 0.356 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.882 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.76 to 0.359 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.604 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to 0.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.562 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -1.16 to 0.454 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy |
|---|---|
| Description | The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 254 | 250 |
| Change at 3 months (n=254, 250) |
0.07
(1.20)
|
0.08
(0.94)
|
| Change at 6 months (n=244, 240) |
-0.02
(1.34)
|
-0.04
(1.14)
|
| Change at 9 months (n=243, 235) |
-0.06
(1.12)
|
-0.07
(1.06)
|
| Change at 12 months (n=233, 233) |
-0.01
(1.20)
|
-0.07
(1.12)
|
| Change at 18 months (n=233, 222) |
-0.03
(1.27)
|
-0.21
(1.20)
|
| Change at 24 months (n=221, 213) |
-0.005
(1.25)
|
-0.12
(1.14)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.892 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.20 to 0.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.881 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.883 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.604 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.118 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.05 to 0.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.307 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.34 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 255 | 252 |
| Change at 3 months (n=255, 252) |
0.06
(2.84)
|
-0.01
(2.77)
|
| Change at 6 months (n=246, 243) |
-0.32
(2.88)
|
-0.1
(3.10)
|
| Change at 9 months (n=243, 236) |
-0.47
(3.05)
|
-0.27
(3.12)
|
| Change at 12 months (n=232, 235) |
-0.03
(2.55)
|
-0.33
(2.86)
|
| Change at 18 months (n=235, 226) |
-0.3
(3.05)
|
-0.04
(3.26)
|
| Change at 24 months (n=222, 214) |
-0.18
(3.05)
|
0.07
(3.09)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.792 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to 0.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.405 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.76 to 0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.484 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to 0.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.229 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.19 to 0.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.381 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.84 to 0.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.405 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.82 to 0.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 254 | 253 |
| Change at 3 months (n=254, 253) |
-0.32
(3.79)
|
-0.18
(3.32)
|
| Change at 6 months (n=246, 244) |
-0.77
(4.31)
|
-0.43
(4.01)
|
| Change at 9 months (n=243, 238) |
-1.03
(3.96)
|
-0.38
(3.62)
|
| Change at 12 months (n=232, 238) |
-0.68
(4.07)
|
-0.91
(4.38)
|
| Change at 18 months (n=232, 227) |
-0.83
(4.14)
|
-0.8
(3.89)
|
| Change at 24 months (n=222, 214) |
-0.91
(4.49)
|
-0.45
(3.72)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.648 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.77 to 0.48 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.366 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.34 | |
| Confidence Interval |
(2-Sided) 95% -1.08 to 0.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 95% -1.33 to 0.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.545 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 1.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.932 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.77 to 0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.244 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to 0.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study |
|---|---|
| Description | The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 255 | 252 |
| Change at 3 months (n=255, 252) |
0.05
(3.76)
|
-0.003
(3.96)
|
| Change at 6 months (n=246, 244) |
-0.33
(4.17)
|
0.17
(4.31)
|
| Change at 9 months (n=243, 239) |
0.3
(3.99)
|
0.48
(4.22)
|
| Change at 12 months (n=233, 238) |
0.61
(4.08)
|
0.38
(4.12)
|
| Change at 18 months (n=233, 227) |
0.06
(4.61)
|
0.67
(4.35)
|
| Change at 24 months (n=222, 214) |
0.36
(4.33)
|
0.72
(4.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 3 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.876 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to 0.73 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.195 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.50 | |
| Confidence Interval |
(2-Sided) 95% -1.25 to 0.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 9 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.630 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.92 to 0.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.530 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 18 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.147 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.61 | |
| Confidence Interval |
(2-Sided) 95% -1.43 to 0.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value was estimated using 2-sided t-test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.389 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -1.18 to 0.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Severe Endocrine Symptoms: QoL Sub-study |
|---|---|
| Description | Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented. |
| Time Frame | Baseline up to 24 months after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 289 | 293 |
| Hot flushes |
151
6.4%
|
146
6.2%
|
| Cold sweats |
60
2.6%
|
52
2.2%
|
| Night sweats |
115
4.9%
|
117
4.9%
|
| Sleeping difficulties |
110
4.7%
|
110
4.6%
|
| Lack of energy |
115
4.9%
|
108
4.6%
|
| Nervous feeling |
68
2.9%
|
65
2.7%
|
| Lightheaded/dizzy |
34
1.4%
|
37
1.6%
|
| Headaches |
56
2.4%
|
49
2.1%
|
| Mood swings |
70
3%
|
66
2.8%
|
| Feeling irritable |
53
2.3%
|
48
2%
|
| Nausea |
16
0.7%
|
14
0.6%
|
| Gained weight |
150
6.4%
|
152
6.4%
|
| Vomiting |
6
0.3%
|
6
0.3%
|
| Diarrhea |
20
0.9%
|
21
0.9%
|
| Bloated feeling |
75
3.2%
|
88
3.7%
|
| Vaginal discharge |
36
1.5%
|
55
2.3%
|
| Vaginal irritation |
37
1.6%
|
45
1.9%
|
| Vaginal bleeding |
10
0.4%
|
11
0.5%
|
| Vaginal dryness |
78
3.3%
|
88
3.7%
|
| Discomfort with intercourse |
47
2%
|
45
1.9%
|
| Lost interest in sex |
128
5.4%
|
142
6%
|
| Breast tenderness |
66
2.8%
|
76
3.2%
|
| Pain |
66
2.8%
|
60
2.5%
|
| Feeling ill |
24
1%
|
24
1%
|
| Side effects |
54
2.3%
|
57
2.4%
|
| Title | Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study |
|---|---|
| Description | Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 61 | 52 |
| 6 months (n=58, 49) |
46.6
2%
|
69.4
2.9%
|
| 12 months (n=60, 52) |
30.0
1.3%
|
55.8
2.4%
|
| 24 months (n=61, 52) |
36.1
1.5%
|
63.5
2.7%
|
| 36 months (n=32, 17) |
21.9
0.9%
|
76.5
3.2%
|
| 6 months post-treatment (n=16, 17) |
31.3
1.3%
|
70.6
3%
|
| 12 months post-treatment (n=50, 37) |
30.0
1.3%
|
32.4
1.4%
|
| 24 months post-treatment (n=41, 31) |
34.1
1.4%
|
29.0
1.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 6 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0174 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0059 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0037 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 12 months post-treatment: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8084 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Exemestane, Tamoxifen |
|---|---|---|
| Comments | 24 months post-treatment: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6449 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Endometrial Thickness: Endometrial Sub-study |
|---|---|
| Description | Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 60 | 52 |
| Baseline (n=60, 52) |
6.0
|
6.0
|
| 6 months (n=58, 49) |
4.0
|
5.9
|
| 12 months (n=59, 52) |
3.3
|
5.5
|
| 24 months (n=60, 52) |
4.0
|
5.0
|
| 36 months (n=31, 17) |
3.0
|
7.0
|
| 6 months post-treatment (n=16, 17) |
3.0
|
5.8
|
| 12 months post-treatment (n=49, 37) |
3.0
|
4.0
|
| 24 months post-treatment (n=40, 31) |
3.0
|
3.8
|
| Title | Uterine and Overall Ovary Volume: Endometrial Sub-study |
|---|---|
| Description | Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. |
| Time Frame | 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 57 | 51 |
| UV: 6 months (n=57, 47) |
25.2
|
36.5
|
| OV: 6 months (n=8, 6) |
1.8
|
1.2
|
| UV: 12 months (n=56, 49) |
23.3
|
39.2
|
| OV: 12 months (n=6, 5) |
2.3
|
2.2
|
| UV: 24 months (n=54, 51) |
26.3
|
40.3
|
| OV: 24 months (n=5, 6) |
2.0
|
2.7
|
| UV: 36 months (n=30, 18) |
21.5
|
36.8
|
| OV: 36 months (n=3, 2) |
1.5
|
2.5
|
| UV: 6 months post-treatment (n=14, 16) |
25.6
|
31.6
|
| OV: 6 months post-treatment (n=2, 4) |
10.1
|
4.7
|
| UV: 12 months post-treatment (n=42, 35) |
21.7
|
30.0
|
| OV: 12 months post-treatment (n=5, 4) |
2.8
|
2.9
|
| UV: 24 months post-treatment (n=38, 28) |
22.6
|
27.8
|
| OV: 24 months post-treatment (n=4, 4) |
1.6
|
3.4
|
| Title | Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study |
|---|---|
| Description | Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline. |
| Time Frame | 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 61 | 52 |
| FIB: 6 months, BL Yes (n=60,50) |
4
0.2%
|
6
0.3%
|
| FIB: 6 months, BL No (n=60,50) |
2
0.1%
|
1
0%
|
| FIB: 6 months, BL Missing (n=60,50) |
2
0.1%
|
0
0%
|
| POL: 6 months, BL Yes (n=60,50) |
0
0%
|
0
0%
|
| POL: 6 months, BL No (n=60,50) |
2
0.1%
|
0
0%
|
| POL: 6 months, BL Missing (n=60,50) |
1
0%
|
0
0%
|
| FIB: 12 months, BL Yes (n=61,52) |
3
0.1%
|
7
0.3%
|
| FIB: 12 months, BL No (n=61,52) |
2
0.1%
|
1
0%
|
| FIB: 12 months, BL Missing (n=61,52) |
4
0.2%
|
1
0%
|
| POL: 12 months, BL Yes (n=61,52) |
0
0%
|
0
0%
|
| POL: 12 months, BL No (n=61,52) |
0
0%
|
0
0%
|
| POL: 12 months, BL Missing (n=61,52) |
1
0%
|
0
0%
|
| FIB: 24 months, BL Yes (n=61,52) |
3
0.1%
|
5
0.2%
|
| FIB: 24 months, BL No (n=61,52) |
3
0.1%
|
0
0%
|
| FIB: 24 months, BL Missing (n=61,52) |
0
0%
|
2
0.1%
|
| POL: 24 months, BL Yes (n=61,52) |
1
0%
|
0
0%
|
| POL: 24 months, BL No (n=61,52) |
0
0%
|
1
0%
|
| POL: 24 months, BL Missing (n=61,52) |
0
0%
|
0
0%
|
| FIB: 36 months, BL Yes (n=33,18) |
2
0.1%
|
1
0%
|
| FIB: 36 months, BL No (n=33,18) |
3
0.1%
|
0
0%
|
| FIB: 36 months, BL Missing (n=33,18) |
0
0%
|
0
0%
|
| POL: 36 months, BL Yes (n=33,18) |
0
0%
|
0
0%
|
| POL: 36 months, BL No (n=33,18) |
1
0%
|
0
0%
|
| POL: 36 months, BL Missing (n=33,18) |
0
0%
|
0
0%
|
| FIB: 6 months post-treatment, BL Yes (n=16,17) |
1
0%
|
0
0%
|
| FIB: 6 months post-treatment, BL No (n=16,17) |
1
0%
|
0
0%
|
| FIB: 6 months post-treatment,BL Missing(n=16,17) |
0
0%
|
2
0.1%
|
| POL: 6 months post-treatment, BL Yes (n=16,17) |
0
0%
|
0
0%
|
| POL: 6 months post-treatment, BL No (n=16,17) |
0
0%
|
0
0%
|
| POL: 6 months post-treatment,BL Missing(n=16,17) |
1
0%
|
0
0%
|
| FIB: 12 months post-treatment, BL Yes (n=51,38) |
1
0%
|
1
0%
|
| FIB: 12 months post-treatment, BL No (n=51,38) |
2
0.1%
|
0
0%
|
| FIB: 12 months post-treatment, BL Missing(n=51,38) |
1
0%
|
1
0%
|
| POL: 12 months post-treatment, BL Yes (n=51,38) |
0
0%
|
0
0%
|
| POL: 12 months post-treatment, BL No (n=51,38) |
0
0%
|
0
0%
|
| POL: 12 months post-treatment, BL Missing (n=51,38 |
0
0%
|
2
0.1%
|
| FIB: 24 months post-treatment, BL Yes (n=43,31) |
2
0.1%
|
2
0.1%
|
| FIB: 24 months post-treatment, BL No (n=43,31) |
2
0.1%
|
1
0%
|
| FIB: 24 months post-treatment, BL Missing(n=43,31) |
1
0%
|
2
0.1%
|
| POL: 24 months post-treatment, BL Yes (n=43,31) |
0
0%
|
0
0%
|
| POL: 24 months post-treatment, BL No (n=43,31) |
1
0%
|
0
0%
|
| POL: 24 months post-treatment, BL Missing(n=43,31) |
2
0.1%
|
1
0%
|
| Title | Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study |
|---|---|
| Description | Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching. |
| Time Frame | Baseline up to 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 86 | 94 |
| Number [percentage of participants] |
16.28
0.7%
|
21.28
0.9%
|
| Title | Number of Participants With Histological Findings: Endometrial Sub-study |
|---|---|
| Description | |
| Time Frame | Baseline up to 24 months post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Results were not reported for this outcome measure because no data was collected as per change in planned analysis. |
| Arm/Group Title | Exemestane | Tamoxifen |
|---|---|---|
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs, AEs collected in separate databases.For SAE:treated population included all randomized participants with at least 1 study drug administration as per actual treatment received.For AE:safety population included all participants in treated population with at least 1 on-treatment AE assessment.AEs included AEs and illnesses reported during study. | |||
| Arm/Group Title | Exemestane | Tamoxifen | ||
| Arm/Group Description | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. | Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. | ||
All Cause Mortality |
||||
| Exemestane | Tamoxifen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Exemestane | Tamoxifen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 383/2320 (16.5%) | 439/2338 (18.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/2320 (0.1%) | 4/2338 (0.2%) | ||
| Disseminated intravascular coagulation | 1/2320 (0%) | 0/2338 (0%) | ||
| Granulocytopenia | 0/2320 (0%) | 1/2338 (0%) | ||
| Hypofibrinogenaemia | 0/2320 (0%) | 1/2338 (0%) | ||
| Iron deficiency anaemia | 1/2320 (0%) | 0/2338 (0%) | ||
| Lymphadenitis | 1/2320 (0%) | 0/2338 (0%) | ||
| Lymphadenopathy | 0/2320 (0%) | 1/2338 (0%) | ||
| Thrombocytopenia | 1/2320 (0%) | 5/2338 (0.2%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 5/2320 (0.2%) | 0/2338 (0%) | ||
| Adams-Stokes syndrome | 0/2320 (0%) | 1/2338 (0%) | ||
| Angina pectoris | 4/2320 (0.2%) | 4/2338 (0.2%) | ||
| Angina unstable | 1/2320 (0%) | 1/2338 (0%) | ||
| Arrhythmia | 1/2320 (0%) | 0/2338 (0%) | ||
| Atrial fibrillation | 7/2320 (0.3%) | 8/2338 (0.3%) | ||
| Atrial flutter | 1/2320 (0%) | 0/2338 (0%) | ||
| Cardiac arrest | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Cardiac disorder | 0/2320 (0%) | 1/2338 (0%) | ||
| Cardiac failure | 6/2320 (0.3%) | 2/2338 (0.1%) | ||
| Cardiac failure congestive | 5/2320 (0.2%) | 3/2338 (0.1%) | ||
| Cardiac valve disease | 1/2320 (0%) | 0/2338 (0%) | ||
| Coronary artery disease | 3/2320 (0.1%) | 2/2338 (0.1%) | ||
| Cyanosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Left ventricular failure | 1/2320 (0%) | 0/2338 (0%) | ||
| Mitral valve incompetence | 1/2320 (0%) | 0/2338 (0%) | ||
| Myocardial infarction | 9/2320 (0.4%) | 5/2338 (0.2%) | ||
| Myocardial ischaemia | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Tachyarrhythmia | 1/2320 (0%) | 0/2338 (0%) | ||
| Tachycardia paroxysmal | 1/2320 (0%) | 1/2338 (0%) | ||
| Ventricular fibrillation | 1/2320 (0%) | 0/2338 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Porphyria non-acute | 0/2320 (0%) | 1/2338 (0%) | ||
| Ear and labyrinth disorders | ||||
| Auricular perichondritis | 0/2320 (0%) | 1/2338 (0%) | ||
| Deafness | 1/2320 (0%) | 0/2338 (0%) | ||
| Deafness unilateral | 0/2320 (0%) | 1/2338 (0%) | ||
| Ear disorder | 1/2320 (0%) | 0/2338 (0%) | ||
| Tinnitus | 1/2320 (0%) | 1/2338 (0%) | ||
| Vertigo | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Endocrine disorders | ||||
| Endocrine disorder | 1/2320 (0%) | 0/2338 (0%) | ||
| Goitre | 4/2320 (0.2%) | 1/2338 (0%) | ||
| Hypothyroidism | 1/2320 (0%) | 0/2338 (0%) | ||
| Thyroiditis | 0/2320 (0%) | 1/2338 (0%) | ||
| Eye disorders | ||||
| Cataract | 3/2320 (0.1%) | 2/2338 (0.1%) | ||
| Eyelid ptosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Optic ischaemic neuropathy | 1/2320 (0%) | 0/2338 (0%) | ||
| Retinal detachment | 1/2320 (0%) | 1/2338 (0%) | ||
| Retinal vein thrombosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Retinopathy | 1/2320 (0%) | 0/2338 (0%) | ||
| Strabismus | 1/2320 (0%) | 0/2338 (0%) | ||
| Visual acuity reduced | 1/2320 (0%) | 1/2338 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 1/2320 (0%) | 1/2338 (0%) | ||
| Abdominal pain | 12/2320 (0.5%) | 6/2338 (0.3%) | ||
| Abdominal pain upper | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Abdominal strangulated hernia | 1/2320 (0%) | 0/2338 (0%) | ||
| Ascites | 1/2320 (0%) | 0/2338 (0%) | ||
| Constipation | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Diarrhoea | 5/2320 (0.2%) | 1/2338 (0%) | ||
| Diverticulitis oesophageal | 0/2320 (0%) | 1/2338 (0%) | ||
| Diverticulum intestinal | 1/2320 (0%) | 1/2338 (0%) | ||
| Dyspepsia | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Enterocele | 1/2320 (0%) | 0/2338 (0%) | ||
| Enterocolitis | 1/2320 (0%) | 0/2338 (0%) | ||
| Faeces discoloured | 1/2320 (0%) | 0/2338 (0%) | ||
| Gastric ulcer | 3/2320 (0.1%) | 0/2338 (0%) | ||
| Gastritis | 1/2320 (0%) | 1/2338 (0%) | ||
| Gastritis erosive | 0/2320 (0%) | 1/2338 (0%) | ||
| Ileus | 0/2320 (0%) | 5/2338 (0.2%) | ||
| Inguinal hernia | 1/2320 (0%) | 1/2338 (0%) | ||
| Intestinal obstruction | 1/2320 (0%) | 1/2338 (0%) | ||
| Melaena | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Nausea | 4/2320 (0.2%) | 1/2338 (0%) | ||
| Pancreatitis | 1/2320 (0%) | 1/2338 (0%) | ||
| Pancreatitis acute | 4/2320 (0.2%) | 0/2338 (0%) | ||
| Rectal haemorrhage | 1/2320 (0%) | 0/2338 (0%) | ||
| Rectal ulcer | 0/2320 (0%) | 1/2338 (0%) | ||
| Salivary gland calculus | 1/2320 (0%) | 0/2338 (0%) | ||
| Small intestinal obstruction | 0/2320 (0%) | 1/2338 (0%) | ||
| Swollen tongue | 1/2320 (0%) | 1/2338 (0%) | ||
| Umbilical hernia, obstructive | 1/2320 (0%) | 0/2338 (0%) | ||
| Volvulus | 0/2320 (0%) | 1/2338 (0%) | ||
| Vomiting | 6/2320 (0.3%) | 2/2338 (0.1%) | ||
| General disorders | ||||
| Asthenia | 1/2320 (0%) | 1/2338 (0%) | ||
| Axillary pain | 1/2320 (0%) | 0/2338 (0%) | ||
| Chest pain | 5/2320 (0.2%) | 4/2338 (0.2%) | ||
| Condition aggravated | 17/2320 (0.7%) | 14/2338 (0.6%) | ||
| Death | 3/2320 (0.1%) | 1/2338 (0%) | ||
| Device failure | 0/2320 (0%) | 1/2338 (0%) | ||
| Disease progression | 4/2320 (0.2%) | 10/2338 (0.4%) | ||
| Disease recurrence | 1/2320 (0%) | 0/2338 (0%) | ||
| Fatigue | 3/2320 (0.1%) | 1/2338 (0%) | ||
| Gait disturbance | 0/2320 (0%) | 1/2338 (0%) | ||
| Granuloma | 0/2320 (0%) | 1/2338 (0%) | ||
| Hernia | 1/2320 (0%) | 1/2338 (0%) | ||
| Hyperplasia | 0/2320 (0%) | 1/2338 (0%) | ||
| Local swelling | 1/2320 (0%) | 0/2338 (0%) | ||
| Multi-organ failure | 1/2320 (0%) | 0/2338 (0%) | ||
| Non-cardiac chest pain | 0/2320 (0%) | 1/2338 (0%) | ||
| Oedema | 1/2320 (0%) | 0/2338 (0%) | ||
| Oedema peripheral | 1/2320 (0%) | 0/2338 (0%) | ||
| Pain | 0/2320 (0%) | 1/2338 (0%) | ||
| Pelvic mass | 1/2320 (0%) | 0/2338 (0%) | ||
| Pyrexia | 1/2320 (0%) | 4/2338 (0.2%) | ||
| Sudden death | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Hepatobiliary disorders | ||||
| Bile duct stone | 1/2320 (0%) | 0/2338 (0%) | ||
| Biliary colic | 1/2320 (0%) | 0/2338 (0%) | ||
| Cholangitis | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Cholecystitis | 2/2320 (0.1%) | 3/2338 (0.1%) | ||
| Cholecystitis acute | 1/2320 (0%) | 0/2338 (0%) | ||
| Cholelithiasis | 7/2320 (0.3%) | 9/2338 (0.4%) | ||
| Gallbladder disorder | 1/2320 (0%) | 0/2338 (0%) | ||
| Hepatic pain | 1/2320 (0%) | 0/2338 (0%) | ||
| Jaundice | 1/2320 (0%) | 0/2338 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 2/2320 (0.1%) | 2/2338 (0.1%) | ||
| Infections and infestations | ||||
| Abdominal hernia gangrenous | 1/2320 (0%) | 0/2338 (0%) | ||
| Abscess | 1/2320 (0%) | 0/2338 (0%) | ||
| Appendicitis | 1/2320 (0%) | 1/2338 (0%) | ||
| Breast cellulitis | 1/2320 (0%) | 0/2338 (0%) | ||
| Bronchitis | 2/2320 (0.1%) | 3/2338 (0.1%) | ||
| Bronchopneumonia | 0/2320 (0%) | 1/2338 (0%) | ||
| Cellulitis | 1/2320 (0%) | 5/2338 (0.2%) | ||
| Cellulitis laryngeal | 0/2320 (0%) | 1/2338 (0%) | ||
| Cystitis | 0/2320 (0%) | 1/2338 (0%) | ||
| Device related infection | 1/2320 (0%) | 0/2338 (0%) | ||
| Diverticulitis | 3/2320 (0.1%) | 1/2338 (0%) | ||
| Ear infection | 1/2320 (0%) | 0/2338 (0%) | ||
| Endocarditis | 1/2320 (0%) | 0/2338 (0%) | ||
| Endometritis | 0/2320 (0%) | 1/2338 (0%) | ||
| Erysipelas | 2/2320 (0.1%) | 4/2338 (0.2%) | ||
| Gastroenteritis | 0/2320 (0%) | 4/2338 (0.2%) | ||
| Herpes zoster | 0/2320 (0%) | 1/2338 (0%) | ||
| Infection | 0/2320 (0%) | 1/2338 (0%) | ||
| Infective exacerbation of chronic obstructive airways disease | 1/2320 (0%) | 0/2338 (0%) | ||
| Lobar pneumonia | 1/2320 (0%) | 0/2338 (0%) | ||
| Localised infection | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Lung infection | 1/2320 (0%) | 0/2338 (0%) | ||
| Lymphangitis | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Mastitis | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Osteomyelitis | 1/2320 (0%) | 0/2338 (0%) | ||
| Otitis media | 0/2320 (0%) | 1/2338 (0%) | ||
| Pneumonia | 10/2320 (0.4%) | 4/2338 (0.2%) | ||
| Pyelonephritis | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Pyelonephritis acute | 1/2320 (0%) | 0/2338 (0%) | ||
| Sepsis | 0/2320 (0%) | 3/2338 (0.1%) | ||
| Septic shock | 0/2320 (0%) | 1/2338 (0%) | ||
| Skin infection | 1/2320 (0%) | 0/2338 (0%) | ||
| Streptococcal sepsis | 0/2320 (0%) | 1/2338 (0%) | ||
| Upper respiratory tract infection | 1/2320 (0%) | 0/2338 (0%) | ||
| Urinary tract infection | 1/2320 (0%) | 4/2338 (0.2%) | ||
| Urosepsis | 0/2320 (0%) | 1/2338 (0%) | ||
| Viral infection | 1/2320 (0%) | 0/2338 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 2/2320 (0.1%) | 4/2338 (0.2%) | ||
| Back injury | 0/2320 (0%) | 1/2338 (0%) | ||
| Clavicle fracture | 1/2320 (0%) | 0/2338 (0%) | ||
| Extradural haematoma | 0/2320 (0%) | 1/2338 (0%) | ||
| Fall | 2/2320 (0.1%) | 6/2338 (0.3%) | ||
| Femoral neck fracture | 3/2320 (0.1%) | 3/2338 (0.1%) | ||
| Femur fracture | 3/2320 (0.1%) | 2/2338 (0.1%) | ||
| Forearm fracture | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Fracture | 7/2320 (0.3%) | 8/2338 (0.3%) | ||
| Head injury | 0/2320 (0%) | 3/2338 (0.1%) | ||
| Hip fracture | 4/2320 (0.2%) | 2/2338 (0.1%) | ||
| Humerus fracture | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Incisional hernia | 0/2320 (0%) | 1/2338 (0%) | ||
| Injury | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Joint dislocation | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Joint injury | 1/2320 (0%) | 0/2338 (0%) | ||
| Ligament injury | 0/2320 (0%) | 1/2338 (0%) | ||
| Limb injury | 0/2320 (0%) | 1/2338 (0%) | ||
| Meniscus injury | 1/2320 (0%) | 1/2338 (0%) | ||
| Multiple fractures | 0/2320 (0%) | 4/2338 (0.2%) | ||
| Patella fracture | 0/2320 (0%) | 1/2338 (0%) | ||
| Postoperative wound complication | 1/2320 (0%) | 0/2338 (0%) | ||
| Pubis fracture | 0/2320 (0%) | 1/2338 (0%) | ||
| Radius fracture | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Retinal injury | 0/2320 (0%) | 1/2338 (0%) | ||
| Road traffic accident | 0/2320 (0%) | 1/2338 (0%) | ||
| Seroma | 1/2320 (0%) | 0/2338 (0%) | ||
| Spinal fracture | 1/2320 (0%) | 1/2338 (0%) | ||
| Tibia fracture | 1/2320 (0%) | 0/2338 (0%) | ||
| Upper limb fracture | 1/2320 (0%) | 0/2338 (0%) | ||
| Wound dehiscence | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Wrist fracture | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Investigations | ||||
| Blood bilirubin increased | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Electrocardiogram QT prolonged | 1/2320 (0%) | 0/2338 (0%) | ||
| Electrocardiogram T wave inversion | 1/2320 (0%) | 0/2338 (0%) | ||
| Liver function test abnormal | 1/2320 (0%) | 0/2338 (0%) | ||
| Platelet count decreased | 1/2320 (0%) | 0/2338 (0%) | ||
| Red blood cell sedimentation rate increased | 1/2320 (0%) | 0/2338 (0%) | ||
| Weight decreased | 0/2320 (0%) | 1/2338 (0%) | ||
| Weight increased | 1/2320 (0%) | 1/2338 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Cachexia | 1/2320 (0%) | 0/2338 (0%) | ||
| Calcification metastatic | 1/2320 (0%) | 0/2338 (0%) | ||
| Decreased appetite | 1/2320 (0%) | 0/2338 (0%) | ||
| Dehydration | 2/2320 (0.1%) | 2/2338 (0.1%) | ||
| Diabetes mellitus | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Diabetic complication | 1/2320 (0%) | 1/2338 (0%) | ||
| Electrolyte imbalance | 1/2320 (0%) | 0/2338 (0%) | ||
| Fluid intake reduced | 1/2320 (0%) | 0/2338 (0%) | ||
| Hypercalcaemia | 1/2320 (0%) | 1/2338 (0%) | ||
| Hypercholesterolaemia | 0/2320 (0%) | 1/2338 (0%) | ||
| Hyperglycaemia | 2/2320 (0.1%) | 2/2338 (0.1%) | ||
| Hyperkalaemia | 1/2320 (0%) | 0/2338 (0%) | ||
| Hyponatraemia | 1/2320 (0%) | 0/2338 (0%) | ||
| Metabolic alkalosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Type 2 diabetes mellitus | 1/2320 (0%) | 0/2338 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 10/2320 (0.4%) | 7/2338 (0.3%) | ||
| Arthritis | 1/2320 (0%) | 0/2338 (0%) | ||
| Arthropathy | 1/2320 (0%) | 0/2338 (0%) | ||
| Back pain | 3/2320 (0.1%) | 2/2338 (0.1%) | ||
| Bone disorder | 0/2320 (0%) | 1/2338 (0%) | ||
| Bone pain | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Enthesopathy | 1/2320 (0%) | 0/2338 (0%) | ||
| Exostosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Fibromyalgia | 1/2320 (0%) | 0/2338 (0%) | ||
| Foot deformity | 0/2320 (0%) | 1/2338 (0%) | ||
| Intervertebral disc disorder | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Intervertebral disc protrusion | 1/2320 (0%) | 0/2338 (0%) | ||
| Lumbar spinal stenosis | 0/2320 (0%) | 1/2338 (0%) | ||
| Mobility decreased | 0/2320 (0%) | 1/2338 (0%) | ||
| Muscle spasms | 1/2320 (0%) | 0/2338 (0%) | ||
| Musculoskeletal pain | 1/2320 (0%) | 1/2338 (0%) | ||
| Myalgia | 1/2320 (0%) | 0/2338 (0%) | ||
| Myopathy | 0/2320 (0%) | 1/2338 (0%) | ||
| Neck pain | 0/2320 (0%) | 1/2338 (0%) | ||
| Osteoarthritis | 8/2320 (0.3%) | 14/2338 (0.6%) | ||
| Osteonecrosis | 0/2320 (0%) | 1/2338 (0%) | ||
| Osteoporosis | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Osteoporotic fracture | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Pain in extremity | 0/2320 (0%) | 1/2338 (0%) | ||
| Rheumatoid arthritis | 0/2320 (0%) | 1/2338 (0%) | ||
| Spinal osteoarthritis | 0/2320 (0%) | 1/2338 (0%) | ||
| Spondylolisthesis | 1/2320 (0%) | 0/2338 (0%) | ||
| Tendon disorder | 1/2320 (0%) | 0/2338 (0%) | ||
| Tendonitis | 0/2320 (0%) | 1/2338 (0%) | ||
| Tenosynovitis | 1/2320 (0%) | 1/2338 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute leukaemia | 1/2320 (0%) | 1/2338 (0%) | ||
| Adenocarcinoma | 1/2320 (0%) | 1/2338 (0%) | ||
| Adenoma benign | 1/2320 (0%) | 1/2338 (0%) | ||
| Adrenal adenoma | 0/2320 (0%) | 1/2338 (0%) | ||
| Anal cancer | 0/2320 (0%) | 1/2338 (0%) | ||
| Basal cell carcinoma | 2/2320 (0.1%) | 5/2338 (0.2%) | ||
| Benign breast neoplasm | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Bile duct cancer | 0/2320 (0%) | 1/2338 (0%) | ||
| Bladder cancer | 1/2320 (0%) | 0/2338 (0%) | ||
| Bladder transitional cell carcinoma | 1/2320 (0%) | 0/2338 (0%) | ||
| Brain neoplasm | 0/2320 (0%) | 1/2338 (0%) | ||
| Brain neoplasm malignant | 1/2320 (0%) | 0/2338 (0%) | ||
| Breast cancer | 9/2320 (0.4%) | 12/2338 (0.5%) | ||
| Breast cancer metastatic | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Breast cancer recurrent | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Cervix carcinoma | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Cervix carcinoma stage II | 0/2320 (0%) | 1/2338 (0%) | ||
| Cervix carcinoma stage III | 0/2320 (0%) | 1/2338 (0%) | ||
| Chronic lymphocytic leukaemia | 1/2320 (0%) | 0/2338 (0%) | ||
| Colon cancer | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Contralateral breast cancer | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Endometrial adenocarcinoma | 1/2320 (0%) | 4/2338 (0.2%) | ||
| Endometrial cancer | 3/2320 (0.1%) | 3/2338 (0.1%) | ||
| Fibroadenoma of breast | 0/2320 (0%) | 1/2338 (0%) | ||
| Gastric cancer | 1/2320 (0%) | 4/2338 (0.2%) | ||
| Hepatic cancer | 0/2320 (0%) | 1/2338 (0%) | ||
| Hepatic cancer metastatic | 1/2320 (0%) | 0/2338 (0%) | ||
| Inflammatory carcinoma of the breast | 0/2320 (0%) | 1/2338 (0%) | ||
| Invasive ductal breast carcinoma | 1/2320 (0%) | 0/2338 (0%) | ||
| Invasive lobular breast carcinoma | 1/2320 (0%) | 0/2338 (0%) | ||
| Keratoacanthoma | 1/2320 (0%) | 0/2338 (0%) | ||
| Leukaemia | 0/2320 (0%) | 1/2338 (0%) | ||
| Lung adenocarcinoma | 0/2320 (0%) | 1/2338 (0%) | ||
| Lung cancer metastatic | 1/2320 (0%) | 0/2338 (0%) | ||
| Lung neoplasm | 0/2320 (0%) | 1/2338 (0%) | ||
| Lung neoplasm malignant | 1/2320 (0%) | 8/2338 (0.3%) | ||
| Lymphoma | 0/2320 (0%) | 1/2338 (0%) | ||
| Malignant melanoma | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Malignant melanoma in situ | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Malignant neoplasm progression | 2/2320 (0.1%) | 4/2338 (0.2%) | ||
| Malignant pleural effusion | 2/2320 (0.1%) | 3/2338 (0.1%) | ||
| Meningioma | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Meningioma benign | 1/2320 (0%) | 0/2338 (0%) | ||
| Mesothelioma | 0/2320 (0%) | 1/2338 (0%) | ||
| Metastases to bone | 3/2320 (0.1%) | 6/2338 (0.3%) | ||
| Metastases to central nervous system | 1/2320 (0%) | 1/2338 (0%) | ||
| Metastases to liver | 3/2320 (0.1%) | 6/2338 (0.3%) | ||
| Metastases to lung | 2/2320 (0.1%) | 6/2338 (0.3%) | ||
| Metastases to lymph nodes | 0/2320 (0%) | 1/2338 (0%) | ||
| Metastases to peritoneum | 1/2320 (0%) | 0/2338 (0%) | ||
| Metastasis | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Metastatic neoplasm | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Neoplasm malignant | 0/2320 (0%) | 1/2338 (0%) | ||
| Neoplasm skin | 1/2320 (0%) | 0/2338 (0%) | ||
| Neuroma | 1/2320 (0%) | 0/2338 (0%) | ||
| Non-Hodgkin's lymphoma | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Non-small cell lung cancer | 1/2320 (0%) | 0/2338 (0%) | ||
| Oesophageal adenocarcinoma | 0/2320 (0%) | 1/2338 (0%) | ||
| Ovarian adenoma | 1/2320 (0%) | 1/2338 (0%) | ||
| Ovarian cancer | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Pancreatic carcinoma | 2/2320 (0.1%) | 3/2338 (0.1%) | ||
| Parathyroid tumour benign | 1/2320 (0%) | 0/2338 (0%) | ||
| Pituitary tumour | 0/2320 (0%) | 1/2338 (0%) | ||
| Plasma cell myeloma | 1/2320 (0%) | 0/2338 (0%) | ||
| Rectal cancer | 1/2320 (0%) | 1/2338 (0%) | ||
| Rectal neoplasm | 0/2320 (0%) | 1/2338 (0%) | ||
| Renal cancer | 1/2320 (0%) | 4/2338 (0.2%) | ||
| Sarcoma | 0/2320 (0%) | 1/2338 (0%) | ||
| Sarcoma uterus | 0/2320 (0%) | 1/2338 (0%) | ||
| Schwannoma | 1/2320 (0%) | 0/2338 (0%) | ||
| Second primary malignancy | 8/2320 (0.3%) | 17/2338 (0.7%) | ||
| Small cell lung cancer | 1/2320 (0%) | 1/2338 (0%) | ||
| Squamous cell carcinoma | 2/2320 (0.1%) | 2/2338 (0.1%) | ||
| Squamous cell carcinoma of skin | 1/2320 (0%) | 0/2338 (0%) | ||
| Thyroid neoplasm | 0/2320 (0%) | 1/2338 (0%) | ||
| Tongue neoplasm malignant stage unspecified | 0/2320 (0%) | 1/2338 (0%) | ||
| Uterine cancer | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Uterine leiomyoma | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Nervous system disorders | ||||
| Amnesia | 0/2320 (0%) | 1/2338 (0%) | ||
| Aphasia | 0/2320 (0%) | 1/2338 (0%) | ||
| Axonal neuropathy | 1/2320 (0%) | 0/2338 (0%) | ||
| Carotid artery occlusion | 0/2320 (0%) | 1/2338 (0%) | ||
| Carotid artery stenosis | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Carpal tunnel syndrome | 9/2320 (0.4%) | 0/2338 (0%) | ||
| Cerebral artery embolism | 0/2320 (0%) | 1/2338 (0%) | ||
| Cerebral haemorrhage | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Cerebral infarction | 3/2320 (0.1%) | 3/2338 (0.1%) | ||
| Cerebral ischaemia | 0/2320 (0%) | 1/2338 (0%) | ||
| Cerebrovascular accident | 10/2320 (0.4%) | 12/2338 (0.5%) | ||
| Cerebrovascular disorder | 1/2320 (0%) | 0/2338 (0%) | ||
| Convulsion | 1/2320 (0%) | 1/2338 (0%) | ||
| Dementia | 1/2320 (0%) | 1/2338 (0%) | ||
| Dementia Alzheimer's type | 0/2320 (0%) | 1/2338 (0%) | ||
| Dizziness | 5/2320 (0.2%) | 2/2338 (0.1%) | ||
| Encephalitis | 0/2320 (0%) | 1/2338 (0%) | ||
| Epilepsy | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Haemorrhage intracranial | 1/2320 (0%) | 1/2338 (0%) | ||
| Headache | 2/2320 (0.1%) | 2/2338 (0.1%) | ||
| Hemiparesis | 0/2320 (0%) | 1/2338 (0%) | ||
| Hyperkinesia | 1/2320 (0%) | 0/2338 (0%) | ||
| Hypoaesthesia | 1/2320 (0%) | 0/2338 (0%) | ||
| Ischaemic stroke | 1/2320 (0%) | 0/2338 (0%) | ||
| Loss of consciousness | 0/2320 (0%) | 1/2338 (0%) | ||
| Lumbar radiculopathy | 0/2320 (0%) | 1/2338 (0%) | ||
| Migraine | 0/2320 (0%) | 1/2338 (0%) | ||
| Neuritis | 0/2320 (0%) | 1/2338 (0%) | ||
| Paraesthesia | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Partial seizures | 0/2320 (0%) | 1/2338 (0%) | ||
| Peripheral sensory neuropathy | 0/2320 (0%) | 1/2338 (0%) | ||
| Radiculopathy | 1/2320 (0%) | 0/2338 (0%) | ||
| Sciatica | 1/2320 (0%) | 1/2338 (0%) | ||
| Subarachnoid haemorrhage | 3/2320 (0.1%) | 0/2338 (0%) | ||
| Syncope | 3/2320 (0.1%) | 3/2338 (0.1%) | ||
| Transient ischaemic attack | 4/2320 (0.2%) | 7/2338 (0.3%) | ||
| Trigeminal neuralgia | 1/2320 (0%) | 0/2338 (0%) | ||
| VIIth nerve paralysis | 1/2320 (0%) | 0/2338 (0%) | ||
| Vascular dementia | 0/2320 (0%) | 1/2338 (0%) | ||
| Psychiatric disorders | ||||
| Alcoholism | 0/2320 (0%) | 1/2338 (0%) | ||
| Anxiety | 1/2320 (0%) | 1/2338 (0%) | ||
| Catatonia | 1/2320 (0%) | 0/2338 (0%) | ||
| Completed suicide | 1/2320 (0%) | 1/2338 (0%) | ||
| Confusional state | 1/2320 (0%) | 1/2338 (0%) | ||
| Depression | 3/2320 (0.1%) | 3/2338 (0.1%) | ||
| Hypomania | 0/2320 (0%) | 1/2338 (0%) | ||
| Mania | 1/2320 (0%) | 0/2338 (0%) | ||
| Mental status changes | 1/2320 (0%) | 0/2338 (0%) | ||
| Schizophrenia | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Suicide attempt | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Renal and urinary disorders | ||||
| Bladder prolapse | 0/2320 (0%) | 1/2338 (0%) | ||
| Calculus ureteric | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Calculus urinary | 0/2320 (0%) | 1/2338 (0%) | ||
| Hydronephrosis | 0/2320 (0%) | 1/2338 (0%) | ||
| Incontinence | 0/2320 (0%) | 1/2338 (0%) | ||
| Nephrolithiasis | 0/2320 (0%) | 1/2338 (0%) | ||
| Renal colic | 2/2320 (0.1%) | 3/2338 (0.1%) | ||
| Renal failure | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Renal failure chronic | 0/2320 (0%) | 1/2338 (0%) | ||
| Urinary bladder haemorrhage | 1/2320 (0%) | 0/2338 (0%) | ||
| Urinary incontinence | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Urinary retention | 0/2320 (0%) | 1/2338 (0%) | ||
| Reproductive system and breast disorders | ||||
| Breast cyst | 1/2320 (0%) | 0/2338 (0%) | ||
| Breast disorder | 1/2320 (0%) | 0/2338 (0%) | ||
| Breast enlargement | 1/2320 (0%) | 0/2338 (0%) | ||
| Cervical dysplasia | 0/2320 (0%) | 1/2338 (0%) | ||
| Cervical polyp | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Colpocele | 0/2320 (0%) | 1/2338 (0%) | ||
| Cystocele | 1/2320 (0%) | 5/2338 (0.2%) | ||
| Ectropion of cervix | 0/2320 (0%) | 1/2338 (0%) | ||
| Endometrial disorder | 1/2320 (0%) | 1/2338 (0%) | ||
| Endometrial hyperplasia | 1/2320 (0%) | 8/2338 (0.3%) | ||
| Endometrial hypertrophy | 2/2320 (0.1%) | 5/2338 (0.2%) | ||
| Genital discharge | 1/2320 (0%) | 0/2338 (0%) | ||
| Metrorrhagia | 4/2320 (0.2%) | 4/2338 (0.2%) | ||
| Ovarian cyst | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Postmenopausal haemorrhage | 0/2320 (0%) | 3/2338 (0.1%) | ||
| Rectocele | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Uterine disorder | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Uterine enlargement | 1/2320 (0%) | 0/2338 (0%) | ||
| Uterine haemorrhage | 1/2320 (0%) | 0/2338 (0%) | ||
| Uterine polyp | 3/2320 (0.1%) | 25/2338 (1.1%) | ||
| Uterine prolapse | 3/2320 (0.1%) | 6/2338 (0.3%) | ||
| Vaginal discharge | 0/2320 (0%) | 1/2338 (0%) | ||
| Vaginal haemorrhage | 7/2320 (0.3%) | 11/2338 (0.5%) | ||
| Vaginal prolapse | 2/2320 (0.1%) | 4/2338 (0.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 1/2320 (0%) | 0/2338 (0%) | ||
| Asthma | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Bronchopneumopathy | 0/2320 (0%) | 1/2338 (0%) | ||
| Bronchospasm | 1/2320 (0%) | 0/2338 (0%) | ||
| Chronic obstructive pulmonary disease | 1/2320 (0%) | 1/2338 (0%) | ||
| Cough | 0/2320 (0%) | 1/2338 (0%) | ||
| Dyspnoea | 6/2320 (0.3%) | 10/2338 (0.4%) | ||
| Emphysema | 1/2320 (0%) | 0/2338 (0%) | ||
| Hypoxia | 1/2320 (0%) | 0/2338 (0%) | ||
| Nasal obstruction | 0/2320 (0%) | 1/2338 (0%) | ||
| Obstructive airways disorder | 0/2320 (0%) | 1/2338 (0%) | ||
| Pleural effusion | 5/2320 (0.2%) | 4/2338 (0.2%) | ||
| Pneumonia aspiration | 1/2320 (0%) | 0/2338 (0%) | ||
| Pulmonary embolism | 4/2320 (0.2%) | 5/2338 (0.2%) | ||
| Respiratory distress | 1/2320 (0%) | 0/2338 (0%) | ||
| Respiratory failure | 1/2320 (0%) | 0/2338 (0%) | ||
| Snoring | 1/2320 (0%) | 0/2338 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/2320 (0%) | 0/2338 (0%) | ||
| Pruritus | 1/2320 (0%) | 0/2338 (0%) | ||
| Rash | 1/2320 (0%) | 1/2338 (0%) | ||
| Rash erythematous | 1/2320 (0%) | 0/2338 (0%) | ||
| Rash papular | 0/2320 (0%) | 1/2338 (0%) | ||
| Skin lesion | 1/2320 (0%) | 1/2338 (0%) | ||
| Skin mass | 1/2320 (0%) | 0/2338 (0%) | ||
| Skin necrosis | 0/2320 (0%) | 1/2338 (0%) | ||
| Skin ulcer | 1/2320 (0%) | 0/2338 (0%) | ||
| Urticaria | 0/2320 (0%) | 1/2338 (0%) | ||
| Surgical and medical procedures | ||||
| Bone graft | 0/2320 (0%) | 1/2338 (0%) | ||
| Breast lump removal | 1/2320 (0%) | 0/2338 (0%) | ||
| Breast prosthesis implantation | 1/2320 (0%) | 2/2338 (0.1%) | ||
| Breast prosthesis removal | 0/2320 (0%) | 1/2338 (0%) | ||
| Breast reconstruction | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Cataract operation | 1/2320 (0%) | 0/2338 (0%) | ||
| Cholecystectomy | 3/2320 (0.1%) | 1/2338 (0%) | ||
| Dacryocystorhinostomy | 1/2320 (0%) | 0/2338 (0%) | ||
| Hip arthroplasty | 2/2320 (0.1%) | 5/2338 (0.2%) | ||
| Hysterectomy | 1/2320 (0%) | 1/2338 (0%) | ||
| Knee arthroplasty | 1/2320 (0%) | 3/2338 (0.1%) | ||
| Knee operation | 1/2320 (0%) | 0/2338 (0%) | ||
| Laparotomy | 0/2320 (0%) | 1/2338 (0%) | ||
| Maxillofacial operation | 0/2320 (0%) | 1/2338 (0%) | ||
| Meniscus operation | 0/2320 (0%) | 1/2338 (0%) | ||
| Nasal septal operation | 0/2320 (0%) | 1/2338 (0%) | ||
| Plastic surgery | 1/2320 (0%) | 0/2338 (0%) | ||
| Prosthesis implantation | 1/2320 (0%) | 0/2338 (0%) | ||
| Scar excision | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Skin graft | 1/2320 (0%) | 1/2338 (0%) | ||
| Surgery | 3/2320 (0.1%) | 1/2338 (0%) | ||
| Thyroidectomy | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Vaginoplasty | 1/2320 (0%) | 0/2338 (0%) | ||
| Varicose vein operation | 0/2320 (0%) | 1/2338 (0%) | ||
| Vitrectomy | 1/2320 (0%) | 0/2338 (0%) | ||
| Vascular disorders | ||||
| Aortic arteriosclerosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Aortic stenosis | 0/2320 (0%) | 1/2338 (0%) | ||
| Arteriosclerosis | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Circulatory collapse | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Deep vein thrombosis | 4/2320 (0.2%) | 22/2338 (0.9%) | ||
| Haematoma | 2/2320 (0.1%) | 1/2338 (0%) | ||
| Hot flush | 2/2320 (0.1%) | 0/2338 (0%) | ||
| Hypertension | 8/2320 (0.3%) | 1/2338 (0%) | ||
| Hypertensive crisis | 1/2320 (0%) | 0/2338 (0%) | ||
| Hypotension | 1/2320 (0%) | 1/2338 (0%) | ||
| Lymphoedema | 0/2320 (0%) | 1/2338 (0%) | ||
| Peripheral artery thrombosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Peripheral ischaemia | 0/2320 (0%) | 1/2338 (0%) | ||
| Phlebitis | 0/2320 (0%) | 2/2338 (0.1%) | ||
| Phlebitis superficial | 0/2320 (0%) | 1/2338 (0%) | ||
| Raynaud's phenomenon | 0/2320 (0%) | 1/2338 (0%) | ||
| Subclavian vein thrombosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Superior vena cava syndrome | 0/2320 (0%) | 1/2338 (0%) | ||
| Thrombophlebitis | 2/2320 (0.1%) | 3/2338 (0.1%) | ||
| Thrombophlebitis superficial | 1/2320 (0%) | 1/2338 (0%) | ||
| Thrombosis | 1/2320 (0%) | 0/2338 (0%) | ||
| Varicose vein | 0/2320 (0%) | 1/2338 (0%) | ||
| Venous thrombosis | 0/2320 (0%) | 1/2338 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Exemestane | Tamoxifen | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1905/2249 (84.7%) | 1888/2279 (82.8%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 200/2249 (8.9%) | 208/2279 (9.1%) | ||
| General disorders | ||||
| Fatigue | 367/2249 (16.3%) | 344/2279 (15.1%) | ||
| Investigations | ||||
| Weight increased | 128/2249 (5.7%) | 138/2279 (6.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 396/2249 (17.6%) | 246/2279 (10.8%) | ||
| Back pain | 208/2249 (9.2%) | 176/2279 (7.7%) | ||
| Osteoarthritis NOS | 138/2249 (6.1%) | 106/2279 (4.7%) | ||
| Osteoporosis NOS | 116/2249 (5.2%) | 66/2279 (2.9%) | ||
| Pain in limb | 143/2249 (6.4%) | 108/2279 (4.7%) | ||
| Nervous system disorders | ||||
| Dizziness | 224/2249 (10%) | 200/2279 (8.8%) | ||
| Headache | 305/2249 (13.6%) | 255/2279 (11.2%) | ||
| Psychiatric disorders | ||||
| Depression | 140/2249 (6.2%) | 127/2279 (5.6%) | ||
| Insomnia | 290/2249 (12.9%) | 205/2279 (9%) | ||
| Reproductive system and breast disorders | ||||
| Vaginal haemorrhage | 89/2249 (4%) | 121/2279 (5.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Sweating increased | 270/2249 (12%) | 242/2279 (10.6%) | ||
| Vascular disorders | ||||
| Hot flushes NOS | 491/2249 (21.8%) | 457/2279 (20.1%) | ||
| Hypertension NOS | 223/2249 (9.9%) | 191/2279 (8.4%) | ||
Limitations/Caveats
Other AEs included both SAEs and AEs. Non-SAE could not be presented separately for this study as AEs were collected in clinical database where SAE flags were not collected.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00038467
Other Study ID Numbers:
- 96-OEXE-031
- A5991012
First Posted:
Jun 3, 2002
Last Update Posted:
May 7, 2014
Last Verified:
Apr 1, 2014