Adjuvant Post-Tamoxifen Exemestane Trial (ATENA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- DFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- effect of exemestane on lipaemic profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2001|
|Study Completion Date:||November 2005|
No Intervention: 1: observation only
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
Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment
Patients randomised to receive exemestane (25 mg/day) for 5 years.
Other Name: Aromasin
- 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.