Adjuvant Post-Tamoxifen Exemestane Trial

Phase 3TerminatedNCT00810706

Hellenic Breast Surgeons Society448 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

448

Conditions

Breast Cancer

Interventions

exemestaneDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hellenic Breast Surgeons Society

Athens, Greece

Outcomes

Primary Outcomes

DFS

Time frame: 5 years

Secondary Outcomes

effect of exemestane on lipaemic profile

Time frame: 2 years

Data from ClinicalTrials.gov

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