Laptinib has recently been approved for breast cancer. The proposed RC0639 study is attempting to define its role in the adjuvant setting. All patients who enroll in this new study must have newly diagnosed, untreated, early-stage HER2-positive breast cancer. After surgery to remove their tumors, patients will receive two chemotherapy drugs intravenously, doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) for two or three months. This will be followed by treatment with another chemotherapy drug, paclitaxel (Taxol), and trastuzumab every week for three months. The study drug, lapatinib, will be added to this phase of treatment. Then, patients will continue to receive trastuzumab treatments every three weeks and will take lapatinib every day for the next nine months. Tests to check heart function will be taken before treatment begins, as well as during and after the study.
This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.
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