Adjuvant Post-Tamoxifen Exemestane Trial (ATENA)

Hellenic Breast Surgeons Society

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer

Treatments: Drug: exemestane

Study type: Interventional

Funder types: Other

Identifiers

NCT00810706

971-ONC-0028-085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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448 participants in 2 patient groups

1: observation only

No Intervention group

Description:

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 group

Description:

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

Treatment:

Drug: exemestane