[A comparative study among ftorafur, ftorafur plus tamoxifen, and tamoxifen in adjuvant therapy for breast cancer. The Chubu Cooperative Study Group of Adjuvant Chemoendocrine Therapy for Breast Cancer, Japan].

A randomized study assessing the efficacy of three treatment of ftorafur (FT), ftorafur plus Tamoxifen (TAM), and Tamoxifen in patients diagnosed as having stage II (N1b) or stage III breast cancer was carried out at 90 institutions in the Chubu district of Japan. After 10 mg of MMC administration on the day of surgery and the next day, patients were allocated to one of three treatments: FT 600 mg/day for 2 years, FT 600 mg/day plus TAM 20 mg/day for 2 years, or TAM 20 mg/day for 2 years. A total of 647 cases were analyzed. No significant differences were observed in the 5-year disease-free survival rates or in the 5-year survival rates. In the stratified analysis, however, a beneficial effect of adding FT to TAM was observed in the patients with ER-positive tumors in the 5-year survival rate, and FT plus TAM treatment was favorable compared with the other two treatments for postmenopausal patients with ER-positive tumors.

RCT Entities:   Population Interventions Outcomes