NIPH Clinical Trials Search

UMIN ID: C000000114

Registered date:05/09/2005

The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedstage I to IIIA breast cancer
Date of first enrollment2004/07/01
Target sample size104
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Doxorubicine+cyclophosphamide followed by paclitaxel, radiotherapy


Primary Outcomepathological complete response rate
Secondary Outcometoxicity, clinical complete response rate, breast conserving rate, relapse free survival, overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
Include criteria
Exclude criteria1) Current history of malignant neoplasms except for curative carcinoma in situ or mucosal carsinoma 2) Pregnant or lactating women or women of childbearing potential 3) Active infectious diesase 4) Past histry of allergic reaction to cremophor EL(polyoxethylated castor oil) or polysorbate 5) Interstitial pneumonia or fibroid lung reveald by chest x-ray 6) Poorly controlled or insulin dependent diabetes mellitus 7) Psychological disease or psychological symptom that interferes with entering this trial

Related Information


public contact
Name Hirofumi Mukai, MD
Address 6-5-1 kashiwahoha, Kashiwa-shi, Chiba, 277-8577, Japan Japan
Affiliation JCOG0306 Coordinating Office Divison of Oncology and Hematology, National Cancer Center Hospital East
scientific contact
Name Toru Watanabe, MD , PhD
Address 117 Shinmachi Hamamatsu, Shizuoka 430-0921, Japan Japan
Affiliation Hamamatsu Oncology Center Medical Oncology