NCT00810706

Adjuvant Post-Tamoxifen Exemestane Trial

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Hellenic Breast Surgeons Society · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	exemestane	Patients randomised to receive exemestane (25 mg/day) for 5 years.

Timeline

• Start date: 2001-04-01
• Completion: 2005-11-01
• First posted: 2008-12-18
• Last updated: 2008-12-18

Locations

1 site across 1 country: Greece