NIPH Clinical Trials Search

UMIN ID: UMIN000001582

Registered date:17/12/2008

Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2008/08/01
Target sample size102
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)4 cycles of TC (Docetaxel 75 mg/m2 / Cyclophosphamide 600mg/m2), every 3 weeks


Primary Outcomecompletion rate
Secondary Outcomesafety, disease-free survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
Include criteria
Exclude criteria1.History of bilateral breast cancer 2.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.HBs antigen positive 11.Treatment required pleural or pericardial effusions 12.Severe peripheral edema (>grade 1) 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.Patients who are required concurrent treatment by corticosteroids except for premedication 15.Severe psychiatric disorders 16.Pregnant or lactation women, or women with suspected pregnancy 17.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
Affiliation Fukuoka University The Department of Medicine, Division of Medical Oncology,Infectious Disease, and Endocrinology School of Medicine