SINGLE ARM, NEOADJUVANT, PHASE II TRIAL OF PERTUZUMAB AND TRASTUZUMAB ADMINISTERED CONCOMITANTLY WITH WEEKLY PACLITAXEL AND FEC FOR CLINICAL STAGE I-III HER2-POSITIVE BREAST CANCER
Subjects will receive 6 months of T-FEC chemotherapy concomitant with trastuzumab and
pertuzumab before surgery. Subsequently, subjects will undergo surgery to remove any cancer
from the breast and axillary lymph nodes that may have survived the chemotherapy. It is
expected that the majority of women will have no viable cancer left in the breast or lymph
nodes by the time all chemotherapy is completed.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response
To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.
Lajos Pusztai, MD
United States: Federal Government
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