Breast Cancer Clinical Trial
Official title:
Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2
on their surface and either kill them or deliver tumor-killing substances to them without
harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone
therapy using exemestane may fight breast cancer by reducing the production of estrogen.
Combining trastuzumab with exemestane may be an effective treatment for breast cancer with
high amounts of HER2.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane
in treating postmenopausal women who have metastatic or locally advanced HER2-positive
breast cancer.
OBJECTIVES:
- Determine the efficacy of exemestane and trastuzumab (Herceptin), in terms of response
rate and time to progression, in postmenopausal women with metastatic or locally
advanced hormone-responsive, HER2/neu positive breast cancer.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1 and oral exemestane
once daily. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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