Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast

Bilateral synchronous breast tumors allowed

Any nodal status or tumor size allowed

No stage IV disease

HER2/neu-positive disease

3+ by IHC OR FISH-amplified
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.1 mg/dL
SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and after completion of study therapy
LVEF ≥ 50% by MUGA scan
No peripheral neuropathy > grade 1
No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix
No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL
No psychiatric illness or concurrent medical conditions that would preclude study treatment

No other conditions, including any of the following:

Unstable angina
Congestive heart failure
Myocardial infarction within the past 12 months
High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)
No QT prolongation (> 500 ms)
No active unresolved infections
No sensitivity to E. coli derived proteins

PRIOR CONCURRENT THERAPY:

Prior hormonal therapy for chemoprevention allowed
No prior trastuzumab (Herceptin®)
No prior anthracyclines
No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)
No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer
No concurrent drugs that may prolong the QT