Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS|
|Study Start Date:||May 1996|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
- 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.
Show 48 Study Locations
|Study Chair:||Robert Paridaens, MD, PhD||U.Z. Gasthuisberg|