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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Dana-Farber Cancer Institute; GlaxoSmithKline; National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Lapatinib; Liposomal doxorubicin; Paclitaxel; Trastuzumab

Criteria

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