NCT00002777

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

RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	exemestane
DRUG	tamoxifen citrate

Timeline

• Start date: 1996-05-01
• Primary completion: 2002-12-01
• First posted: 2003-04-11
• Last updated: 2012-07-02

Locations

48 sites across 12 countries: Australia, Belgium, France, Malaysia, Netherlands, Philippines, Poland, Russia, Slovenia, Taiwan, Thailand, United Kingdom