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Adjuvant Post-Tamoxifen Exemestane Trial

NCT00810706 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2008-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

exemestane

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

Sponsors & Collaborators

  • Hellenic Breast Surgeons Society

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Completion
2005-11-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00810706 on ClinicalTrials.gov