Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

Study Overview
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Brief Summary
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To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years) 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. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

Official Title
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Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: exemestane
* Drug: tamoxifen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HR+ post-menopausal patients with non-metastatic breast cancer Exclusion Criteria: Any of the following: HR-, non-menopausal patient, metastatic breast cancer

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: A<br> | Drug: exemestane<br>* On tablet of 25 mg per day during 5 years<br>* Other names: Aromasin;|
| Active Comparator: B<br> | Drug: tamoxifen<br>* Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment<br>* Other names: Kessar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare recurrence free survival between two treatment groups. |  | 2.75 years and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of life of patients treated with exemestane to that of patients treated with tamoxifen |  | Every 3 months during first year then every 6 months for 4 years | 
| Overall survival between the 2 treatment groups |  | Every 3 months during first year then every 6 months for 4 years | 
| Incidence of a second breast cancer (contralateral) between the 2 treatment groups |  | Every 3 months during first year then every 6 months for 4 years | 
| General tolerance in the short- and long-term between the 2 treatment groups |  | Every 3 months during first year then every 6 months dor 4 years |