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

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 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