Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01239745
• Collaborator: (none)
• Enrollment: 46
• Locations: 11
• Duration (Months): 6
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.

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

Detailed Description

The study prematurely discontinued on October 11, 2011 due to slow enrollment. 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: 46 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1	Drug: Aromasin; Aromasin® one 25 mg tablet to be taken once daily; Other Names: Exemestane

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) [Baseline up to Month 36]

   Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Secondary Outcome Measures

1. Number of Participants With Concomitant Morbidities [Baseline up to Month 36]

   Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.

2. Number of Participants With Concomitant Medications [Baseline up to Month 36]

   Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.

3. Percentage of Participants Who Discontinued the Study Medication [Baseline up to Month 36]

4. Number of Participants With Reasons for Discontinuation From Study Medication [Baseline up to Month 36]

5. Time to Discontinuation [Baseline up to Month 36]

6. Recurrence-free Survival [Baseline up to Month 36]

   Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.

7. Overall Survival [Baseline until death (up to Month 36)]

   Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Postmenopausal females, defined as one from the next :

1. Natural menopause ≥1 year,

2. Surgical ovariectomy,

3. Chemotherapy-induced amenorrhoea ≥ 2 years.

• Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.

• Patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment.

• Patients whose tumour was estrogen receptor positive (ER+).

• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Patients for whom Aromasin® treatment is contraindicated (see SmPC).

• Metastatic breast cancer or a contra lateral tumour.

• Other concomitant adjuvant endocrine therapy.

• Other concomitant antineoplastic treatment.

• Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital Karlovac	Karlovac		Croatia	47000
2	University Hospital Center Osijek	Osijek		Croatia	31000
3	General Hospital Pula	Pula		Croatia	52000
4	University Hospital Center Rijeka	Rijeka		Croatia	51000
5	University Hospital Center Split	Split		Croatia	21000
6	General Hospital Varazdin	Varazdin		Croatia	42000
7	Clinic for Tumors	Zagreb		Croatia	10000
8	University Hospital Center "Sestre milosrdnice"	Zagreb		Croatia	10000
9	North Estonia Medical Centre Foundation	Tallinn		Estonia	13419
10	Institute for Oncology and Radiology of Serbia	Belgrade		Serbia	11000
11	Oncology Clinic, Medical center, Bezanijska Kosa	Beograd		Serbia	11080

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: NCT01239745
• Other Study ID Numbers: A5991094
• First Posted: Nov 11, 2010
• Last Update Posted: Oct 31, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Pfizer: Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
• Additional relevant MeSH terms: Breast Neoplasms; Exemestane

Study Results

Participant Flow

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Period Title: Overall Study
STARTED	46
COMPLETED	0
NOT COMPLETED	46

Baseline Characteristics

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Overall Participants	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.0 (10.7)
Sex: Female, Male (Count of Participants)
Female	46 100%
Male	0 0%
Type of Tumor (participants) [Number]
Invasive ductal carcinoma	31 67.4%
Invasive lobular carcinoma	7 15.2%
Papillary carcinoma	0 0%
Medullary carcinoma	1 2.2%
Mucinous (colloid) carcinoma	2 4.3%
Other	5 10.9%
Type of Surgery (participants) [Number]
Number [participants]	NA NaN
Hormone Receptor Status (participants) [Number]
Number [participants]	46 100%
Lymph Node Status (participants) [Number]
Number [participants]	NA NaN
Tumor Node Metastasis (TNM) Stage (participants) [Number]
Stage I	18 39.1%
Stage IIA	14 30.4%
Stage IIB	5 10.9%
Stage IIIB	4 8.7%
Stage IV	0 0%
Stage IIIA	4 8.7%
Stage IIIC	0 0%
Other	1 2.2%
Histopathological Grade (participants) [Number]
Grade 1	10 21.7%
Grade 2	19 41.3%
Grade 3	7 15.2%
Unknown	10 21.7%
Number of participants on chemotherapy (participants) [Number]
Number [participants]	NA NaN
Number of participants on radiotherapy (participants) [Number]
Number [participants]	NA NaN
Concomitant morbidities in the past (participants) [Number]
Cholelithiasis	1 2.2%
Intracranial aneurysm	1 2.2%
Cystitis noninfective	1 2.2%
Reproductive tract disorder	3 6.5%
Hypertension	3 6.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Safety analysis set included participants who received at least one dose of the study medication during the observation period.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	46
Number [participants]	2 4.3%

2. Secondary Outcome

Title	Number of Participants With Concomitant Morbidities
Description	Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Safety analysis set included participants who received at least one dose of the study medication during the observation period.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	46
Coronary artery disease	1 2.2%
Glaucoma	1 2.2%
Scotoma	1 2.2%
Crohn's disease	1 2.2%
Fatigue	1 2.2%
Multiple allergies	1 2.2%
Skin infection	1 2.2%
Diabetes mellitus	1 2.2%
Arthralgia	2 4.3%
Collagen disorder	1 2.2%
Intervertebral disc protrusion	1 2.2%
Osteoporosis	3 6.5%
Headache	1 2.2%
Depression	1 2.2%
Hypertension	8 17.4%

3. Secondary Outcome

Title	Number of Participants With Concomitant Medications
Description	Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Safety analysis set included participants who received at least one dose of the study medication during the observation period.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	46
Number [participants]	0 0%

4. Secondary Outcome

Title	Percentage of Participants Who Discontinued the Study Medication
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	0

5. Secondary Outcome

Title	Number of Participants With Reasons for Discontinuation From Study Medication
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	0

6. Secondary Outcome

Title	Time to Discontinuation
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	0

7. Secondary Outcome

Title	Recurrence-free Survival
Description	Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	0

8. Secondary Outcome

Title	Overall Survival
Description	Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame	Baseline until death (up to Month 36)

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.

Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Exemestane
Arm/Group Description	Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
All Cause Mortality
	Exemestane
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Exemestane
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Other (Not Including Serious) Adverse Events
	Exemestane
	Affected / at Risk (%)	# Events
Total	2/46 (4.3%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/46 (2.2%)
Vascular disorders
Hot flush	1/46 (2.2%)

Limitations/Caveats

The study was prematurely discontinued, therefore not all data was analyzed.

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.