Adjuvant Post-Tamoxifen Exemestane Trial (ATENA)
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|ClinicalTrials.gov Identifier: NCT00810706|
Recruitment Status : Terminated (Publication of MA17 results (similar trial in the extented adjuvant setting with letrozole))
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: exemestane||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||448 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2001|
|Actual 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
- DFS [ Time Frame: 5 years ]
- effect of exemestane on lipaemic profile [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810706
|Hellenic Breast Surgeons Society|
|Athens, Greece, 11527|