An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00776659
• Collaborator: (none)
• Enrollment: 39
• Locations: 4
• Duration (Months): 45
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.

• Efficacy of the treatment with Aromasin®

• Safety of the treatment with Aromasin®

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Other: Aromasin

Detailed Description

NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Study Design

• Study Type: Observational
• Actual Enrollment: 39 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Observational	Other: Aromasin; Non-Interventional study design.; Other Names: exemestane

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer [Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)]

   Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.

2. Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer [Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)]

3. Number of Participants Who Died [Baseline until death (up to Year 3.5)]

4. Number of Participants Who Discontinued Aromasin Therapy [Baseline until discontinuation (up to Year 3.5)]

5. Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) [Baseline up to 28 days after last dose of study treatment]

   An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.

6. Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42 [Baseline, Month 6, 12, 18, 24, 30, 36, 42]

7. Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 [Baseline, Month 6, 12, 18, 24, 30, 36, 42]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

Exclusion Criteria:

• Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included.

• Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bangalore	Karnataka	India	560 029
2	Pfizer Investigational Site	Ludhiana	Punjab	India	141 004
3	Pfizer Investigational Site	Ludhiana	Punjab	India	141 009
4	Pfizer Investigational Site	Lucknow	Uttar Pradesh	India	226 001

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00776659
• Other Study ID Numbers: A5991088
• First Posted: Oct 21, 2008
• Last Update Posted: Nov 19, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Pfizer: An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin; Antineoplastic Hormonal Drugs; Aromasin
• Additional relevant MeSH terms: Breast Neoplasms; Exemestane

Study Results

Participant Flow

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Period Title: Overall Study
STARTED	39
COMPLETED	13
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Overall Participants	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.0 (10.7)
Sex: Female, Male (Count of Participants)
Female	39 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Description	Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Time Frame	Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	7
Locoregional/Distant Recurrence	0 0%
Missing/No response	1 2.6%

2. Primary Outcome

Title	Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Time Frame	Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	7
Second primary or contralateral breast cancer	0 0%
Missing/No response	1 2.6%

3. Primary Outcome

Title	Number of Participants Who Died
Time Frame	Baseline until death (up to Year 3.5)

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received at least 1 dose of aromasin therapy.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	39
Number [participants]	0 0%

4. Primary Outcome

Title	Number of Participants Who Discontinued Aromasin Therapy
Time Frame	Baseline until discontinuation (up to Year 3.5)

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received at least 1 dose of aromasin therapy.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	39
Number [participants]	26 66.7%

5. Primary Outcome

Title	Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
Time Frame	Baseline up to 28 days after last dose of study treatment

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received at least 1 dose of aromasin therapy.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	39
Gynecological AEs	0 0%
Cardiac AEs	0 0%
Venous thromboembolic events	0 0%
Musculoskeletal AEs	0 0%
Menopausal symptoms	2 5.1%

6. Primary Outcome

Title	Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42
Time Frame	Baseline, Month 6, 12, 18, 24, 30, 36, 42

Outcome Measure Data

Analysis Population Description

Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	0

7. Primary Outcome

Title	Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
Time Frame	Baseline, Month 6, 12, 18, 24, 30, 36, 42

Outcome Measure Data

Analysis Population Description

Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
Measure Participants	0

Adverse Events

Arm/Group Title	Exemestane
Arm/Group Description	Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
All Cause Mortality
	Exemestane
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Exemestane
	Affected / at Risk (%)	# Events
Total	0/39 (0%)
Other (Not Including Serious) Adverse Events
	Exemestane
	Affected / at Risk (%)	# Events
Total	10/39 (25.6%)
Gastrointestinal disorders
Abdominal distension	1/39 (2.6%)
Gastritis	1/39 (2.6%)
Nausea	1/39 (2.6%)
General disorders
Oedema	1/39 (2.6%)
Oedema peripheral	1/39 (2.6%)
Infections and infestations
Nasopharyngitis	1/39 (2.6%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/39 (2.6%)
Nervous system disorders
Convulsion	1/39 (2.6%)
Dizziness	1/39 (2.6%)
Headache	2/39 (5.1%)
Migraine	1/39 (2.6%)
Paraesthesia	1/39 (2.6%)
Reproductive system and breast disorders
Breast pain	1/39 (2.6%)
Skin and subcutaneous tissue disorders
Erythema	1/39 (2.6%)
Pruritus allergic	2/39 (5.1%)
Vascular disorders
Lymphoedema	1/39 (2.6%)

Limitations/Caveats

Study was terminated due to slow enrollment and observational nature of the study. Low number of participants enrolled was not sufficient to conduct the planned analysis. Study was not terminated due to safety concerns.

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.