Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma of the breast
• •Nonmetastatic disease
• •* Positive or negative axillary nodes
• •* Tumor size ≥ 10 mm
• •Resectable disease
• •Must have received ≥ 4 courses of chemotherapy for this disease
• •A 12-month adjuvant treatment with trastuzumab (Herceptin®) has been initiated
• •* Informed consent form must be signed between the third and sixth months of trastuzumab therapy
• •Overexpression of HER-2 in the invasive component of the primary tumor as indicated by 1 of the following:
• •* 3+ by immunohistochemistry (IHC)
• •* 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
• •Hormone receptor status not specified
• •PATIENT CHARACTERISTICS:
• •Female
• •Menopausal status not specified
• •LVEF considered favorable for continuing trastuzumab treatment as measured by echocardiography or MUGA at 2-4 months after beginning adjuvant trastuzumab
• •No serious cardiac illness or medical condition precluding trastuzumab treatment, including any of the following:
• •* History of documented congestive heart failure
• •* High-risk uncontrolled arrhythmias
• •* Angina pectoris requiring antianginal medication
• •* Severe dyspnea at rest or oxygen-dependent
• •No known hypersensitivity to trastuzumab, murine proteins, or any of the excipients
• •Not pregnant or nursing
• •No social, geographical, or psychological condition that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Other prior anti-HER-2 therapy allowed
• •No prior trastuzumab other than initiation of trastuzumab adjuvant therapy