Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00002777
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.

Detailed Description

OBJECTIVES:

* Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer.

* Determine the safety profile of exemestane in these patients.

* Compare the overall survival of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only).

Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 18 months and then at least every 6 months thereafter.

PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study within 4.7 years.

Study Timeline

• Study Start: 1996-05
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-12
• Study First Submitted QC: 2003-04-10
• Study First Posted: 2003-04-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 342

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (48)

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

Bankstown - Lidcombe Hospital; 🇦🇺 Bankstown, Australia

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

Institut Jules Bordet; 🇧🇪 Brussels (Bruxelles), Belgium

Centre Hospitalier Etterbeek Ixelles; 🇧🇪 Brussels (Bruxelles), Belgium

Hopital de Jolimont; 🇧🇪 Haine Saint Paul, Belgium

Centre Hospitalier Universitaire de Tivoli; 🇧🇪 La Louviere, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

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