Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer
• Clinical stage I-III disease
• Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan
• HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization
• No known brain metastases
• Hormone receptor status unspecified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Male or female
• Life expectancy > 12 weeks
• ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500 mm^3
• Platelet count ≥ 100,000/mm^3
• Total bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• LVEF ≥ 50% as measured by echocardiogram or MUGA scan
• No other malignancy within the past year
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to swallow and retain oral medication
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
• No ongoing or active infection
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
• No malabsorption syndrome
• No requirement for IV alimentation
• No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer
• No prior treatment with epidermal growth factor receptor targeting therapies
• No prior surgical procedures affecting absorption
• No prior surgery for breast cancer
• At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
• Dexamethasone or dexamethasone equivalent dose ≥ 1.5 mg/day, including any of the following:
• Cortisone (≥ 50 mg/day)
• Hydrocortisone (≥ 40 mg/day)
• Prednisone (≥ 10 mg/day)
• Methylprednisolone (≥ 8 mg/day)
• Phenytoin
• Carbamazepine
• Phenobarbital
• Efavirenz
• Nevirapine
• Rifampin
• Rifabutin
• Rifapentine
• Hypericum perforatum (St. John's wort)
• Modafinil
• At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
• Clarithromycin
• Erythromycin
• Troleandomycin
• Delavirdine
• Ritonavir
• Indinavir
• Saquinavir
• Nelfinavir
• Amprenavir
• Lopinavir
• Itraconazole
• Ketoconazole
• Voriconazole
• Fluconazole (doses up to 150 mg/day are permitted)
• Nefazodone
• Fluvoxamine
• Verapamil
• Diltiazem
• Cimetidine
• Aprepitant
• Grapefruit or its juice
• At least 6 months since prior and no concurrent amiodarone
• At least 2 days since prior and no concurrent gastric pH modifiers*, including any of the following:
• Cimetidine
• Ranitidine
• Nizatidine
• Famotidine
• Omeprazole
• Esomeprazole
• Rabeprazole
• Pantoprazole
• Lansoprazole
• NOTE: *Antacids are allowed within 1 hour before and after administration of study drug
• No other concurrent investigational agents
• No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy
• No concurrent herbal (alternative) medicines
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Concurrent bisphosphonates allowed