Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: exemestane; Drug: tamoxifen

• Registration Number: NCT00279448
• Lead Sponsor: Pfizer

Brief Summary

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial \[971-ONC-0028-081/A5991026\] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081\&rank=1

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-19
• Primary Completion: 2008-11
• Study Completion: 2009-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9779

Inclusion Criteria

• HR+ post-menopausal patients with non-metastatic breast cancer

Exclusion Criteria

• Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	exemestane	-
B	tamoxifen	-

Primary Outcome Measures

Name	Time	Method
To compare recurrence free survival between two treatment groups.	2.75 years and 5 years

Secondary Outcome Measures

Name	Time	Method
The quality of life of patients treated with exemestane to that of patients treated with tamoxifen	Every 3 months during first year then every 6 months for 4 years
Overall survival between the 2 treatment groups	Every 3 months during first year then every 6 months for 4 years
Incidence of a second breast cancer (contralateral) between the 2 treatment groups	Every 3 months during first year then every 6 months for 4 years
General tolerance in the short- and long-term between the 2 treatment groups	Every 3 months during first year then every 6 months dor 4 years

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Vannes, France