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