Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed diagnosis of early-stage breast cancer
• * HER2 positive by immunohistochemistry (IHC) (3+) or fluorescent in situ hybridization (FISH)
• * Ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification
• No locally advanced tumors (i.e., T4) at diagnosis, including the following:
• * Tumors fixed to chest wall
• * Peau d'orange
• * Skin ulcerations or nodules
• * Clinical inflammatory changes (e.g., diffuse brawny cutaneous induration with an erysipeloid edge)
• Has undergone mastectomy or lumpectomy with axillary node or sentinel node dissection within the past 84 days
• * Patients who have undergone a mastectomy must meet the following criteria:
• * No evidence of gross or microscopic tumor (i.e., invasive DCIS) at the surgical resection margins noted in final surgery or pathology reports
• * Patients with close margins are eligible
• * Radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy
• * Patients who have undergone a lumpectomy with axillary node or sentinel node dissection must meet the following criteria:
• * No evidence of invasive cancer or DCIS at the surgical resection margins
• * No gross residual adenopathy
• * Planning to undergo radiation therapy to the breast with or without regional lymphatics after completion of chemotherapy
• No active hepatic or biliary disease
• * Patients with liver metastases, stable chronic liver disease, Gilbert's syndrome, or asymptomatic gallstones are eligible
• Hormone receptor status:
• * Estrogen receptor and progesterone receptor status known
• PATIENT CHARACTERISTICS:
• Male or female
• Menopausal status not specified
• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• LVEF ≥ 50% by MUGA scan or echocardiogram
• Able to complete questionnaire(s) by themselves or with assistance
• Able and willing to provide blood and tissue samples
• No known sensitivity to benzyl alcohol
• No sensory neuropathy ≥ grade 2
• No active cardiac disease, including any of the following:
• * Myocardial infarction within the past 6 months
• * Prior or concurrent congestive heart failure
• * Prior or concurrent arrhythmia or cardiac valvular disease requiring medications or that is clinically significant
• * Uncontrolled hypertension, defined as diastolic blood pressure (BP) \>100 mm Hg or systolic BP \> 200 mm Hg on 2 separate occasions ≥ 14 days apart
• * Clinically significant pericardial effusion
• * Prior or concurrent uncontrolled or symptomatic angina
• * Other cardiac condition that, in the opinion of the treating physician, would put the patient at hazardous risk
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition as lapatinib ditosylate
• No uncontrolled intercurrent illness including, but not limited to, the following:
• * Ongoing or active infection
• * Psychiatric illness or social situations that would preclude study compliance
• Able to swallow and retain oral medication
• * No history of gastrointestinal (GI) disease resulting in an inability to take oral medication, including any of the following:
• * Malabsorption syndrome
• * Requirement for IV alimentation
• * Prior surgical procedures affecting absorption
• * Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
• No primary breast radiation therapy as part of breast-conserving treatment
• No prior anthracycline or taxane therapy for any malignancy
• No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib, cetuximab, erlotinib hydrochloride, rituximab, trastuzumab \[Herceptin®\], lapatinib ditosylate, panitumumab, or nimotuzumab)
• At least 14 days since prior and no concurrent CYP3A4 inducers, including the following:
• * Rifamycin-class antibiotics (e.g., rifampin, rifabutin, or rifapentine)
• * Anticonvulsants (e.g., phenytoin, carbamazepine, or barbiturates \[e.g., phenobarbital\])
• * Antiretrovirals (e.g., efavirenz or nevirapine)
• * Glucocorticoids (e.g., oral cortisone, hydrocortisone, prednisone, methylprednisolone, or dexamethasone)
• * Daily oral dexamethasone ≤ 1.5 mg (or equivalent) allowed
• * Modafinil
• * Hypericum perforatum (St. John's wort)
• At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:
• * Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin)
• * Antifungals (e.g., itraconazole, ketoconazole, fluconazole \[\> 150 mg daily\], or voriconazole)
• * Antiretrovirals and protease inhibitors (e.g., delaviridine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, or lopinavir)
• * Calcium channel blockers (e.g., verapamil or diltiazem)
• * Antidepressants (e.g., nefazodone or fluvoxamine)
• * Gastrointestinal agents (e.g., cimetidine or aprepitant)
• * Grapefruit and grapefruit juice
• At least 6 months since prior and no concurrent amiodarone
• No herbal or alternative medicines or supplements ≥ 14 days before, during, and for 30 days after completion of study treatment
• No concurrent hormonal agents (e.g., birth control pills, ovarian hormonal replacement therapy, or raloxifene)
• * Adjuvant hormonal agents (e.g., tamoxifen, aromatase inhibitors) allowed after completion of chemotherapy as part of treatment for breast cancer
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent digitalis or beta-blockers for congestive heart failure
• No concurrent arrhythmia or angina pectoris medication
• No other concurrent investigational agents or anticancer therapies, including cytotoxic agents or immunotherapy