NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000013469

Registered date:20/03/2014

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

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 enrollment2007/09/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional,observational
Intervention(s)S-1

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaPatients with serious complications, a history of drug hypersensitivity, brain metastases with any symptoms, active secondary cancer, or pregnant women

Related Information

Contact

public contact
Name Takashi Shigekawa
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
Telephone +81-42-984-4670
E-mail t.shigekawa@gmail.com
Affiliation Saitama Medical University International Medical Center Breast Oncology
scientific contact
Name Toshiaki Saeki
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
Telephone +81-42-984-4670
E-mail takshige@saitama-med.ac.jp
Affiliation Saitama Medical University International Medical Center Breast Oncology