Safety and feasibility of adjuvant chemotherapy with S-1 in Japanese breast cancer patients after primary systemic chemotherapy: a feasibility multicenter study

UMIN ID: UMIN000013469

Registered date:20/03/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: (1) breast cancer with histological confirmation; (2) stage II or III breast cancer and previous standard anthracycline and/or taxane-based PSC, followed by curative surgery; (3) age 20-75 years; (4) Eastern Cooperative Oncology Group performance status 0,1; (5) adequate gastrointestinal function; (6) adequate organ function
• Date of first enrollment: 2007/09/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional,observational
• Intervention(s): S-1

Outcome(s)

• Primary Outcome: The primary endpoint was the percentage of the scheduled adjuvant chemotherapy completed using S-1 calculated by the Kaplan Meier method.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Patients with serious complications, a history of drug hypersensitivity, brain metastases with any symptoms, active secondary cancer, or pregnant women

Related Information

• Primary Sponsor: Saitama Medical University International Medical Center
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare Grant-in-Aid for Scientific Research