Trial | NCT00810706  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    exemestane ...

  • Study Participants

    448
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.
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 Started
Apr 30
2001
Study Completion
Nov 30
2005
Last Update
Dec 18
2008
Estimate

Drug exemestane

Patients randomised to receive exemestane (25 mg/day) for 5 years.

  • Other names: Aromasin

1: observation only No Intervention

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.

2: Exemestane Active Comparator

Patients randomised to receive exemestane (25 mg/day) for 5 years, following completion of 5-7 years of Tamoxifen treatment

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
No Results Posted