Prospective Multicenter Randomized Phase III Study of Weekly versus Standard Docetaxel plus Doxorubicin (D4) for First-Line Treatment of Metastatic Breast Cancer

Purpose: Previous phase II studies have indicated a greatly reduced hematotoxicity of docetaxel-based regimens administered on weekly schedules. The present trial was initiated to compare the toxicity and efficacy of weekly docetaxel versus its standard 3-weekly application in combination with doxorubicin. Methods: Patients previously untreated with chemotherapy for metastatic disease were recruited. Inclusion criteria were age ! 65 years or a Karnofsky Performance Status of 70–100%. All patients in the D4 study received doxorubicin (50 mg/m 2 ) on the first day of treatment in addition to docetaxel given either at a 3-weekly dose of 75 mg/m 2 every 3 weeks (q3w) or at a weekly dose of 35 mg/m 2 (days 1, 8, and 15; q4w). Treatment was continued until a maximum of 8 cycles, unacceptable toxicity, or disease proReceived: June 24, 2010 Accepted: July 27, 2010 Published online: March 1, 2011 Oncology PD Dr. H.J. Stemmler, Medical Department III (Hematology-Oncology) Klinikum Grosshadern, University of Munich Marchioninistrasse 15, DE–81377 Munich (Germany) Tel. +49 89 7095 3026, Fax +49 89 7095 8828 E-Mail Joachim.Stemmler @ med.uni-muenchen.de © 2011 S. Karger AG, Basel 0030–2414/10/0794–0204$26.00/0 Accessible online at: www.karger.com/ocl H.-J.S. and N.H. contributed equally to this paper.