NIPH Clinical Trials Search

UMIN ID: UMIN000001736

Registered date:27/02/2009

Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPrimary breast cancer
Date of first enrollment2008/09/01
Target sample size32
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Paclitaxel 80mg/m2 every week for 12 cycles. 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles. Operation is to be offered to the patients with breast cancer as a curative intent within 2 months after neoadjuvant chemotherapy.


Primary OutcomePathological complete response rate
Secondary OutcomeSafety Clinical efficacy Overall survival Disease free survival Breast-conserving rate

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
Include criteria
Exclude criteria1. Severe medical conditions 2. Suspected infectious disease 3. Alergy to clemohol EL 4. Severe peripheral neuropathy 5. Pregnant or lactating women

Related Information


public contact
Name Kazuo Tamura
Address 1-8-17-204, Watanabe-dori, Chuo-ku, Fukuoka Japan
Telephone 092-406-4166
Affiliation Kyushu Breast Cancer Study Group Executive office
scientific contact
Name Maki Tanaka
Address 21 Kushihara-Cho, Kurume Japan
Telephone 0942-33-1211
Affiliation Kurume Daiichi Social Insurance Hospital Surgery