NIPH Clinical Trials Search

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) studied	Primary breast cancer
Date of first enrollment	2002/06/01
Target sample size	200
Countries of recruitment	Japan
Study type	Interventional
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

Outcome(s)

Primary Outcome	Clinicl response, pathologic response, safety
Secondary Outcome	Breast-conserving rate, overall survival, disease free survival

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	65years-old
Gender	Female
Include criteria
Exclude criteria	Hypersensitivity for drug Serious coexisting illness Active double cancer Bilateral breast cancer Male breast cancer Pregnant or postpartum women