Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab; cyclophosphamide; doxorubicin hydrochloride; lapatinib ditosylate; paclitaxel; laboratory biomarker analysis
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer

Summary:

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

Eligibility 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