Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the breast
• * Stage IIIB, IIIC, or IV
• * HER2-positive
• Measurable or evaluable disease
• * Patients with osteolytic bone lesions as only site of disease must have at least 2 lytic sites confirmed by bone x-ray, MRI, or CT scan
• * None of the following are eligible as only manifestation of metastatic disease:
• * Blastic bone metastases
• * Mixed bone metastases
• * Lymphangitic carcinomatosis
• * Ascites
• * Pleural/pericardial effusion
• * Lymphangitis cutis/pulmonis
• * Inflammatory breast disease
• * Abdominal masses not confirmed and followed by imaging techniques
• * Cystic lesions
• No prior or known concurrent clinical manifestation of brain or leptomeningeal involvement
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 to 75
• Sex
• Female
• Menopausal status
• Pre- or post-menopausal
• Performance status
• Karnofsky 60-100%
• Life expectancy
• Not specified
• Hematopoietic
• Neutrophil count at least 2,000/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin at least 10 g/dL
• Hepatic
• Bilirubin no greater than upper limit of normal (ULN)
• AST and ALT no greater than 5 times ULN
• Alkaline phosphatase no greater than 5 times ULN (unless due to bone metastases or any nonmalignant bone disease and in absence of liver disorders)
• AST and/or ALT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN ineligible
• Renal
• Creatinine no greater than 2 mg/dL
• Creatinine clearance at least 60 mL/min
• Cardiovascular
• LVEF normal by MUGA or echocardiogram
• No myocardial infarction within the past year
• No unstable angina pectoris
• No documentation of congestive heart failure
• No concurrent grade 3 or 4 cardiovascular arrhythmia
• No poorly controlled hypertension (i.e., diastolic pressure greater than 100 mmHg)
• Pulmonary
• No severe dyspnea due to complications of advanced malignancy
• No respiratory insufficiency requiring supplemental oxygen
• Other
• No significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude study
• No pre-existing sensory or motor neuropathy grade 2 or greater
• No other serious illness or medical condition
• No active uncontrolled infection
• No active peptic ulcer disease
• No unstable diabetes mellitus
• No other prior or concurrent malignancy except for:
• * Curatively treated nonmelanoma skin cancer
• * Carcinoma in situ of the cervix
• * Other curatively treated cancer and disease free for at least 10 years
• No known allergic reactions to study drugs
• No contraindications for the use of corticosteroids
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• See Chemotherapy
• No prior trastuzumab (Herceptin) for locally advanced or metastatic disease
• Prior trastuzumab-containing regimen (except with taxane) as adjuvant or neoadjuvant therapy allowed provided relapse occurred at least 6 months after therapy
• Chemotherapy
• No prior chemotherapy for locally advanced or metastatic disease or local recurrence
• No prior chemotherapy with anthracycline or anthracenedione regimens with cumulative doses of more than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
• No prior platinum-containing regimen as adjuvant or neoadjuvant chemotherapy
• At least 4 weeks since prior anthracyclines or anthracenediones
• Prior taxanes as adjuvant or neoadjuvant chemotherapy allowed provided relapse occurred at least 6 months after therapy
• Prior taxane with trastuzumab as adjuvant or neoadjuvant chemotherapy allowed provided relapse occurred at least 12 months after therapy
• No concurrent amifostine
• Endocrine therapy
• Prior hormonal therapy in the adjuvant or metastatic setting allowed provided patient has progressive disease and therapy has stopped before study entry
• Concurrent chronic corticosteroids allowed if initiated more than 6 months before study entry and at a low dose (no greater than 20 mg methylprednisolone or equivalent)
• No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulators
• No concurrent hormonal therapy
• Radiotherapy
• No prior radiotherapy to study lesion unless clear progression
• At least 4 weeks since prior radiotherapy (unless radiotherapy involved only a single field to treat a single metastatic bone lesion)
• Concurrent radiotherapy for palliative treatment allowed
• Surgery
• Not specified
• Other
• Recovered from prior antitumor therapy
• At least 30 days since prior experimental drugs
• No other concurrent experimental drugs
• No other concurrent anticancer therapy
• No concurrent bisphosphonates if osteolytic bone metastases are only site of disease
• * If receiving concurrent bisphosphonates other than for bone metastases only, must have been started at least 3 months before study entry
• No concurrent primary prophylactic antibiotics
• No concurrent cardioprotectors (e.g., dexrazoxane)