OncRef

Clinical Trial: NCT00279448

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Pfizer
Information Provided By:Pfizer
Last Update Posted:2011-12-23

Study Overview

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

Official Title

Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

Conditions

Breast Neoplasms

Intervention / Treatment

  • Drug: exemestane
  • Drug: tamoxifen

Other Study ID Numbers

  • EXEAPO-0028-118
  • A5991081

Start Date

2002-01

Primary Completion Date (Actual)

2008-11

Study Completion Date (Actual)

2009-06

Enrollment (Actual)

9779

Study Type

Interventional

Phase

Phase 3