Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane plus goserelin may fight breast cancer by reducing the production of estrogen.
PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating premenopausal women who have metastatic breast cancer that has not responded to previous tamoxifen.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of the Combination of Exemestane and Goserelin in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer|
|Study Start Date:||June 2000|
|Primary Completion Date:||May 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the efficacy of exemestane and goserelin in premenopausal women with hormone receptor positive metastatic breast cancer after tamoxifen failure. II. Determine the toxicity of this regimen in these patients. III. Determine the hormonal profile of patients treated with this regimen. IV. Determine the predictive value of HER-2, epidermal growth factor receptor, and estrogen receptor for response in patients treated with this regimen.
OUTLINE: Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010010
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Anne Hamilton, MD, FRACP||New York University School of Medicine|