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Breast Cancer Research

Open Access

Phase I study of combination therapy with weekly paclitaxel and cyclophosphatamide for advanced or recurrent breast cancer

  • T Nakayama1,
  • N Masuda2,
  • J Yamamura2,
  • S Kamigaki3,
  • T Taguchi1,
  • M Hatta4 and
  • J Sakamoto4
Breast Cancer Research200911(Suppl 1):P17

Published: 23 June 2009


Breast CancerPaclitaxelNeutropeniaDocetaxelAnthracycline


Although anthracycline is a key agent in breast cancer treatment, there is a concern that it may cause cardiotoxicity. Recently, the usefulness of combined therapy with docetaxel and cyclophos-phamide (C) was reported. Because paclitaxel (P) has different features, such as induction of apoptosis and anti-angiogenic activity on weekly administration, establishment of combination therapy of P/C is required. We initiated a phase I study to determine the maximum tolerated dose and the recommended dose (RD) of the combination therapy of P/C for advanced or recurrent breast cancer.


P was given intravenously on days 1, 8 and 15 and C on day 1, every 3 weeks. P was given at 80 mg/m2 for level 1 and 100 mg/m2 for level 2, and C at 600 mg/m2 for both. Onset of dose-limiting toxicity was evaluated during course 1, and tolerability through course 4.


Four patients each were enrolled in levels 1 and 2 from October 2006 to November 2007. Main adverse events were four cases of grade 3 neutropenia (50%) and one case of peripheral nerve disorder (12.5%). During the first course of levels 1 and 2, hematologic toxicity of grade 4 and nonhematologic toxicity of grade 3 or higher were not observed, and a MTD was not attained. The response rate among assessable cases (one in level 1, two in level 2) was 66.7%.


Safety was confirmed during four courses at level 2, and this was regarded as the RD. This is the first report on the phase I study of the combination therapy of weekly P and C, and its safety and efficacy should be evaluated in the phase II trial.

Authors’ Affiliations

Graduate School of Medicine, Department of Breast and Endocrine Surgery, Osaka University, Osaka, Japan
Department of Surgery, Breast Oncology Group, Osaka National Hospital, Osaka, Japan
Department of Surgery, Sakai Municipal Hospital, Osaka, Japan
Graduate School of Medicine, Social Life Science, Young Leaders' Program, Nagoya University, Aichi, Japan


© BioMed Central Ltd. 2009