Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

Study Overview
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Brief Summary
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To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.

Official Title
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Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: exemestane (Aromasin)
* Drug: tamoxifen + exemestane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated. Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered. Exclusion Criteria: Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria: Inflammatory breast cancer Histologically positive supraclavicular nodes Ulceration/infiltration of local skin metastasis Neoadjuvant chemotherapy Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion ER and PR negative primary tumor or ER/PR unknown status.

Ages Eligible for Study
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Minimum Age: 50 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exemestane<br> | Drug: exemestane (Aromasin)<br>* exemestane, orally, 25 mg, for 5 years<br>* Other names: aromasin;|
| Experimental: tamoxifen + exemestane<br> | Drug: tamoxifen + exemestane<br>* tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years | Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse. | Baseline (Month 0) up to 2.75 years | 
| Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years | Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse. | Baseline (Month 0) up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Events for Overall Survival (OS) | Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact. | Baseline (Month 0) up to 5 years | 
| Time to New Primary Breast Cancers | New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC). | Baseline (Month 0) up to 5 years | 
| Number of Events for Time to Relapse | Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer. | Baseline (Month 0) up to 5 years | 
| Number of Participants With New Primary Non-breast Cancers | Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types. | Baseline (Month 0) up to 5 years |