NIPH Clinical Trials Search

UMIN ID: C000000397

Registered date:06/04/2006

Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2005/12/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)4 cycles of FEC (Fluorouracil 500 mg/m2 / Epirubicin 75 mg/m2 / Cyclophosphamide 500mg/m2), every 3 weeks, then 4 cycles•of Docetaxel 70 mg/m2 every 3 weeks.


Primary OutcomeDisease-free survival
Secondary OutcomeSafety, feasibility

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
Include criteria
Exclude criteria1) Bilateral breast cancer 2)A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 3)Inflammatory breast cancer 4)Male 5)A history of hypersensitivity reaction to any drugs. 6)Uncontrolled medical conditions. 7)Suspected of infection with fever 8)Severe peripheral neuropathy (>Grade 1). 9)Symptomatic varicella. 10)Treatment required pleural or pericardial effusions 11)Severe peripheral edema. 12)Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13)Patients who are required concurrent treatment by corticosteroids. 14)Severe psychiatric disorders 15)Pregnant or lactation women, or women with suspected pregnancy 16)Patients judged by the investigator to be unfit to be enrolled into the study

Related Information


public contact
Name Kazuo Tamura
Address 7-45-1,Nanakuma, Jonan-ku, Fukuoka Japan
Telephone 092-801-2845
Affiliation Kyushu Breast Cancer Study Group Executive office
scientific contact
Name Kazuo Tamura
Address 7-45-1,Nanakuma, Jonan-ku, Fukuoka Japan
Telephone 092-801-1011
Affiliation Fukuoka University Internal Medicine, School of Medicine