NIPH Clinical Trials Search

UMIN ID: C000000011

Registered date:22/06/2005

Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPrimary breast cancer
Date of first enrollment2002/06/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Primary systemic chemotherapy (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2, q3w x 4 cycles, followed by docetaxel 75 mg/m2, q3w x 4 cycles


Primary OutcomeClinicl response, pathologic response, safety
Secondary OutcomeBreast-conserving rate, overall survival, disease free survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum65years-old
Include criteria
Exclude criteriaHypersensitivity for drug Serious coexisting illness Active double cancer Bilateral breast cancer Male breast cancer Pregnant or postpartum women

Related Information


public contact
Name Katsumasa Kuroi
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan Japan 103-0016
Telephone 03-6264-8873
Affiliation JBCRG Head Office
scientific contact
Name 1)Masakazu 2)Yuichi 1)Toi 2)Takatsuka
Address 54 Kawara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan Japan
Telephone 075-751-3660
Affiliation 1)Graduate School of Medicine Kyoto University 2)Kansai Rosai Hospital 1)Department of Surgery (Breast Surgery) 2)Department of Breast Surgery