Randomized study of taxane versus TS-1 in women with metastatic or recurrent breast cancer (SELECT BC).
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.
Mukai
Hirofumi
H
Division of Oncology/Hematology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan. hrmukai@east.ncc.go.jp
Takashima
Tsutomu
T
Hozumi
Yasuo
Y
Watanabe
Takanori
T
Murakami
Shigeru
S
Masuda
Norikazu
N
Mitsuyama
Shoshu
S
Ohmura
Tousei
T
Yajima
Tamiko
T
Ohashi
Yasuo
Y
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000191:economics; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000401:mortality; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010094:Oxonic Acid / Q000627:therapeutic use*; D017239:Paclitaxel / Q000008:administration & dosage*; D011788:Quality of Life; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage*; D005641:Tegafur / Q000627:therapeutic use*
D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D017239:Paclitaxel