Conditions: Breast Cancer
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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 95
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.

Interventions: intervention 1: trastuzumab intervention 2: cyclophosphamide intervention 3: doxorubicin hydrochloride intervention 4: lapatinib ditosylate intervention 5: paclitaxel intervention 6: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol document: