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Japanese Journal of Clinical Oncology
Year: 2010  |  Volume: 40  |  Issue: 8  |  Page No.: 811 - 814

Randomized Study of Taxane Versus TS-1 in Women with Metastatic or Recurrent Breast Cancer (SELECT BC)

H Mukai, T Takashima, Y Hozumi, T Watanabe, S Murakami, N Masuda, S Mitsuyama, T Ohmura, T Yajima and Y. Ohashi    

Abstract:

This randomized controlled trial will compare oral 5-fluorouracil derivatives, TS-1, with intravenous standard chemotherapy such as taxanes in women with metastatic or recurrent breast cancer. Patients with hormone-resistant breast cancer are assigned to either TS-1 (40–60 mg twice daily for 28 consecutive days, followed by a 14-day rest period) or standard chemotherapy (docetaxel 60–75 mg/m2 at 3- or 4-week intervals, paclitaxel 175 mg/m2 at 3- or 4-week intervals or paclitaxel 80–100 mg/m2 weekly, followed by a 1-week rest period). Treatment will be repeated until tumor progression or ≥4 courses for TS-1 and ≥6 courses for taxanes. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, time to treatment failure, adverse events, health-related quality of life and cost-effectiveness. A threshold hazard ratio of 1.333 will be used to determine whether overall survival in the TS-1 group is equivalent (not inferior) to that in the taxane group. The target number of registered patients is 600.

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