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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.
Full description
OBJECTIVES:
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Stage IV or locally advanced disease
HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry
Measurable disease defined by 1 of the following criteria:
Evaluable disease defined by 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal by 1 of the following criteria:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Data sourced from clinicaltrials.gov
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