Breast Cancer Clinical Trial
Official title:
A Phase II Study of the Combination of Exemestane and Goserelin in Premenopausal Women With Metastatic Hormone Receptor Positive 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.
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.
;
Primary Purpose: Treatment
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