Adjuvant Post-Tamoxifen Exemestane Trial

• Status: Terminated
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Breast Surgeons Society
• Treatments: Exemestane; Tamoxifen

Criteria

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