• Clinical breast cancer · Oct 2008

    Randomized Controlled Trial Multicenter Study

    Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT00629278).

    • Valentina Guarneri, Antonio Frassoldati, Paolo Bruzzi, Roberto D'Amico, Maurizio Belfiglio, Annamaria Molino, Oscar Bertetto, Stefano Cascinu, Francesco Cognetti, Angelo Di Leo, Paolo Pronzato, Lucio Crinó, Biagio Agostara, and PierFranco Conte.
    • Division of Medical Oncology, Department of Oncology and Hematology, University Hospital, Modena, Italy.
    • Clin. Breast Cancer. 2008 Oct 1; 8 (5): 453-6.

    AbstractTrastuzumab, a monoclonal antibody against the HER2 receptor, is currently approved as a part of adjuvant therapy for patients with HER2-overexpressing breast tumors. The Short-HER study is a phase III randomized, multicentric Italian trial aimed at testing the optimal duration of adjuvant trastuzumab. In this trial, 2500 patients with HER2-positive breast cancer will be randomized to receive the following: (arm A, long) 4 courses of anthracycline- based chemotherapy (doxorubicin/cyclophosphamide or epidoxorubicin/cyclophosphamide) followed by 4 courses of docetaxel or paclitaxel in combination with trastuzumab, followed by 14 additional courses of trastuzumab administered every 3 weeks (for a total of 18 3-weekly doses of trastuzumab); or (arm B, short) 3 courses of 3-weekly docetaxel in combination with weekly trastuzumab (for a total of 9 weekly doses of trastuzumab) followed by 3 courses of 5-fluorouracil/epirubicin/cyclophosphamide. The primary objective is disease-free survival.

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