Randomized study of taxane versus TS-1 in women with metastatic or recurrent breast cancer (SELECT BC).

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/m(2) at 3- or 4-week intervals, paclitaxel 175 mg/m(2) at 3- or 4-week intervals or paclitaxel 80-100 mg/m(2) weekly, followed by a 1-week rest period). Treatment will be repeated until tumor progression or > or =4 courses for TS-1 and > or =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.

• Authors: Hirofumi Mukai, Tsutomu Takashima, Yasuo Hozumi, Takanori Watanabe, Shigeru Murakami, Norikazu Masuda, Shoshu Mitsuyama, Tousei Ohmura, Tamiko Yajima, Yasuo Ohashi
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 40 Issue 8 Pg. 811-4 (Aug 2010) ISSN: 1465-3621 [Electronic] England
• PMID: 20462978 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antimetabolites, Antineoplastic
• Antineoplastic Agents
• Drug Combinations
• Taxoids
• S 1 (combination)
• Tegafur
• Docetaxel
• Oxonic Acid
• Paclitaxel

Topics

• Administration, Oral
• Adult
• Aged
• Antimetabolites, Antineoplastic (therapeutic use)
• Antineoplastic Agents (administration & dosage, economics)
• Breast Neoplasms (drug therapy, economics, mortality)
• Cost-Benefit Analysis
• Disease Progression
• Disease-Free Survival
• Docetaxel
• Drug Administration Schedule
• Drug Combinations
• Female
• Humans
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Recurrence, Local (drug therapy)
• Oxonic Acid (therapeutic use)
• Paclitaxel (administration & dosage)
• Quality of Life
• Survival Rate
• Taxoids (administration & dosage)
• Tegafur (therapeutic use)