Status:
TERMINATED
Adjuvant Post-Tamoxifen Exemestane Trial
Lead Sponsor:
Hellenic Breast Surgeons Society
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00810706
Start Date
April 1 2001
End Date
November 1 2005
Last Update
December 18 2008
Active Locations (1)
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1
Hellenic Breast Surgeons Society
Athens, Greece, 11527