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Breast Cancer Res. Treat. · Jan 2006
Multicenter StudyMulticenter phase II study of trastuzumab in combination with epirubicin and docetaxel as first-line treatment for HER2-overexpressing metastatic breast cancer.
- M Venturini, C Bighin, S Monfardini, F Cappuzzo, N Olmeo, A Durando, F Puglisi, O Nicoletto, A Lambiase, and L Del Mastro.
- Division of Medical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. marco.venturini@istge.it
- Breast Cancer Res. Treat. 2006 Jan 1; 95 (1): 45-53.
AbstractThe primary objective of study is to evaluate cardiac safety of trastuzumab in combination with epirubicin and docetaxel. HER2-overexpressing metastatic breast cancer patients were enrolled in a two-stage, multicenter phase II trial with weekly trastuzumab (4 and then 2 mg/kg) with epirubicin and docetaxel (either 75 mg/m(2)) on day 1 every 3 weeks. After eight courses of chemotherapy, trastuzumab was continued as a single agent. To assess cardiotoxicity, patients were evaluated for left ventricular ejection fraction (LVEF) at baseline, every two cycles during chemotherapy and trastuzumab, and every 3 months during trastuzumab alone. Cardiotoxicity was defined as signs and/or symptoms of congestive heart failure (CHF) and/or an absolute decrease in LVEF of >or=20 units or a decline to
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