Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the following criteria:
• * Nonmetastatic disease
• * Operable and adequately excised
• * Patients with nonresectable deep margin invasion are eligible provided they have had or will receive radiotherapy to the region
• * Patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumor bed
• * Node-positive OR -negative and determined eligible to receive adjuvant trastuzumab (Herceptin®)
• No positive or suspicious internal mammary nodes by SNS that have not been or will not be irradiated
• No supraclavicular lymph node involvement (confirmed by fine needle aspiration or biopsy)
• Over expression and/or amplification of HER2 in the invasive component of the primary tumor, according to one of the following:
• * 3+ over-expression by IHC (\> 30% of invasive tumor cells)
• * 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification
• * HER2 gene amplification by FISH/CISH (\> 6 HER2 gene copies per nucleus, or a FISH ratio \[HER2 gene copies to chromosome 17 signals\] of \> 2.2.)
• * Negative or equivocal overall result (FISH test ratio of \< 2.2, \< 6.0 HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in 30% or less neoplastic cells) by IHC not allowed
• Hormone receptor status known (estrogen receptor with or without progesterone receptor)
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• ECOG performance status 0-1
• Hemoglobin ≥ 10.0 g/dL
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)
• Baseline LVEF ≥ 50% measured by ECHO or MUGA scan
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No serious cardiac illness or medical condition including, but not limited to, any of the following:
• * History of documented congestive heart failure (any NYHA class) or systolic dysfunction (LVEF \< 50%)
• * High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade atrioventricular-block \[second degree or higher\], or supraventricular arrhythmias that are not adequately rate-controlled)
• * Angina pectoris requiring antianginal medication
• * Clinically significant valvular heart disease
• * Evidence of transmural infarction on ECG
• * Poorly controlled hypertension (any reading of systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg)
• No other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions or illness
• None of the following:
• * Ulcerative colitis
• * Malabsorption syndrome
• * Any disease significantly affecting gastrointestinal function
• * Inability to swallow oral medication
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior mediastinal irradiation except internal mammary-node irradiation for the present breast cancer
• No prior anti-HER2 therapy for any reason
• No prior biologic or immunotherapy for breast cancer
• No prior resection of the stomach or small bowel
• No other concurrent anticancer therapy including chemotherapeutic agents, biologic agents, or radiotherapy
• No concurrent anticancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the study chair
• No concurrent CYP3A4 inhibitors or inducers
• No concurrent epoetin alfa, including darbepoetin alfa
• No concurrent oprelvekin