Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed invasive breast cancer
• •No evidence of metastatic disease
• •Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by fluorescent in situ hybridization (FISH) gene amplification
• •Indication for chemotherapy based on the following clinical and histopathological features:
• •* Receiving or scheduled to receive neoadjuvant chemotherapy
• •* Time between diagnosis biopsy and start date of chemotherapy should be less than 1 month
• •* Receiving or scheduled to receive adjuvant chemotherapy
• •* Completely resected disease, with negative surgical margins (apart from deep margin if full thickness resection)
• •* Marginally resected disease and/or positive sentinel nodes allowed provided patients undergo completion of surgery (breast and/or axillary clearance) after chemotherapy
• •Hormone receptor status known
• •PATIENT CHARACTERISTICS:
• •Menopausal status not specified
• •ECOG performance status 0-1
• •Adequate bone marrow, hepatic, and renal function
• •LVEF normal by ECHO or MUGA
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No clinically significant cardiac abnormalities
• •No myocardial infarction within the past 6 months
• •No uncontrolled or malignant hypertension
• •No history of atrioventricular arrhythmia and/or congestive heart failure (even under medical control), or active second or third degree cardiac block
• •No history of allergy to drugs containing polysorbate 20 and the excipient polysorbate 80 (TWEEN 80®) or history of allergy to mouse proteins
• •No co-morbidity significantly adding to risks associated with cytotoxic chemotherapy (i.e., severe chronic obstructive pulmonary disease or poorly controlled diabetes)
• •No prior diagnosis of malignancy unless managed by surgical treatment only and disease-free for 10 years
• •* Prior basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast allowed if treated by surgery only
• •No concomitant medical or psychiatric problems that might preclude completion of treatment or follow-up
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No prior chemotherapy or radiotherapy
• •Concurrent radiotherapy allowed