Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.

Official Title
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Follow-up of the Study 971-ONC-0028-080: Exemestane Versus Megestrol Acetate In Postmenopausal Patients With Metastatic Breast Cancer, Failing Anti-Estrogens: An Open-Label, Randomized, Parallel-Group, Phase III Comparative Study

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Megestrol acetate
* Drug: exemestane (Aromasin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous participation in study 971-ONC-0028-080. Exclusion Criteria: Subjects who had not previously participated in study 971-ONC-0028-080.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Megestrol acetate<br>* Megestrol Acetate 160 mg oral tablets Qd<br>* Other names: Megace;|
| Experimental: 2<br> | Drug: exemestane (Aromasin)<br>* exemestane (Aromasin) 25 mg oral tablets Qd<br>* Other names: Aromasin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival in months measured from date of starting treatment in core study to date of death for any reason. | Every 12 weeks up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group | Every 12 weeks up to 6 years | 
| Duration of Response (DR) | Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response. | Every 12 weeks up to 6 years | 
| Time to Tumor Progression (TTP) | TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions. | Every 12 weeks up to 6 years | 
| Time to Treatment Failure (TTF) | TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event. | Every 12 weeks up to 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Breast Cancer, Advanced, Postmenopausal, Exemestane vs Megestrol