Adjuvant Post-Tamoxifen Exemestane Trial

Study Overview
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Brief Summary
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The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5 years of adjuvant exemestane versus 5 years of observation in postmenopausal women with operable breast cancer who have received 5-7 years of adjuvant tamoxifen. The primary endpoint for the core protocol is disease-free survival (DFS). Exemestane treatment is planned for 5 years unless disease relapse or excessive toxicity is documented, the patient refuses further treatment or any new anti-cancer therapy is initiated.

Detailed Description
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Patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry. A substudy (ATENA lipid substudy)is designed to evaluate changes in the patients' serum lipid profile during study treatment.

Official Title
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A Phase III Randomized Parallel-Group Multicenter Trial, Designed to Compare 5 Years of Adjuvant Exemestane Versus 5 Years of Observation in Postmenopausal Women With Operable Breast Cancer Who Have Received 5-7 Years of Adjuvant Tamoxifen.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: exemestane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postmenopausal women only histologically confirmed stage I-IIIA primary adenocarcinoma of the breast estrogen and/or progesterone receptors positive or unknown patients should have undergone surgery with a curative intent patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry Absence of any evidence of local or distant metastatic disease was required prior to randomization Exclusion Criteria: DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| No Intervention: 1: observation only<br>Patients have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day). Tamoxifen could have been discontinued up to 6 months prior to study entry. | |
| Active Comparator: 2: Exemestane<br>Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment | Drug: exemestane<br>* Patients randomised to receive exemestane (25 mg/day) for 5 years.<br>* Other names: Aromasin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of exemestane on lipaemic profile |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Aromatase inhibitors, Exemestane, Tamoxifen, Lipids