NIPH Clinical Trials Search

UMIN ID: UMIN000001583

Registered date:17/12/2008

Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2008/08/01
Target sample size45
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)As FEC regimen, 5-fluorouracil 500 mg/m2 iv, epirubicine 100 mg/m2 iv and cyclophophamide 500 mg/m2 iv every 3 weeks, repeated 4 cycles Docetaxel 75 mg/m2 iv every 3 weeks, repeated 4 cycles following FEC. Trastuzumab beginning with a loading dose of 8 mg/kg of body weight, iv given with the first dose of Docetaxel and followed by does of 6 mg/kg iv every 3 weeks, repeated 4 cycles. Total duration of trastuzumab will be 1 year.


Primary OutcomeCompletion rate of the treatment according with the protocol
Secondary OutcomeSafety Postponement rate as compared to planned treatment schedule Dose reduction rate as compared to planned doses of chemotherapeutic agents

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
Include criteria
Exclude criteria1. Clinical or radiological evidence of metastatic breast cancer 2. complication of the active other malignancies 3. Serious cardiac disfunction 4. Uncontrolled medical conditions 5. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 6. Patients who are required concurrent treatment by corticosteroids except for premedication 7 .Severe psychiatric disorders 8. Pregnant or lactation women, or women with suspected pregnancy 9. History of hypersensitivity reaction to drug formulated with Polysorbate 80 10. Patients judged by the investigator to be unfit to be enrolled into the study

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 Kazuo Tamura
Address 7-45-1 Nanakuma Jonan-ku Fukuoka Japan
Telephone 092-801-1011
Affiliation Fukuoka University The Department of Medicine, Division of Medical Oncology, Infectious Disease, and Endocrinology School of Medicine