NIPH Clinical Trials Search

UMIN ID: UMIN000002365

Registered date:31/08/2009

A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer (JBCRG 10)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHER2 positive breast cancer
Date of first enrollment2009/08/01
Target sample size180
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1)FEC-TCH therapy group: 4 cycles of FEC therapy * (5-fluorouracil (5-FU) + epirubicin (EPI) + cyclophosphamide (CPA)) followed by 4 cycles of TCH therapy ** (docetaxel (DTX) + cyclophosphamide (CPA) + trastuzumab (H)) *FEC regimen: 1 cycle is 3 weeks; 5-FU (500 mg/m2, q3w), epirubicin (100 mg/m2, q3w), cyclophosphamide (500 mg/m2, q3w) **TCH regimen: 1 cycle is 3 weeks; docetaxel (75 mg/m2, q3w), cyclophosphamide (600 mg/m2, q3w) 2)TCH-FEC therapy group: 4 cycles of TCH therapy** followed by 4 cycles of FEC therapy 3)TCH therapy group: 6 cycles of TCH therapy


Primary Outcomepathological complete rseponse rate
Secondary OutcomeSafety, incidence of cardiac disorders, clinical response rate, overall survival, breast conservation rate and rate without axillary lymph node dissection

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
Include criteria
Exclude criteria1)Hypersensitivity to any agents necessary in the planned treatment. 2)Poorly controlled complication (malignant hypertension, myocardial infarction within 6 months, congestive heart failure, coronary insufficiency, arrhythmia which requires treatment, infection and bleeding). 3)Fever with suspected infection. 4)Symptoms of varicella. 5)Pleural effusion or cardiac effusion which requires treatment. 6)Serious edema. 7)Serious peripheral neuropathy 8)Complication which requires prior treatment with corticosteroid. 9)Regular use of H2 blocker. 10)Has history of or receiving treatment for serious psychiatric disorder. 11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 12)Multiple primary cancer or has history of multiple primary cancer in the past 5 years. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 13)History of invasive breast cancer. 14)History of multiple primary cancers in the past 5 years excluding nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer appropriately treated. 15)Prior treatment with anticancer agents. 16)Cardiac disorder diagnosed by echocardiography. 17)Women who are pregnant, lactating or with childbearing potential. 18)Ineligible based on decision of an investigator.

Related Information


public contact
Name Katsumasa Kuroi
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan Japan
Telephone 03-6264-8873
Affiliation Japan Breast Cancer Research Group (JBCRG) Adminstrative office
scientific contact
Name Masakazu Toi1), Norikazu Masuda2), Takayuki Ueno3)
Address 1) 54 Syougoinkawaracho, sakyou-ku, kyouto-City, Kyoto, 2) 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka, 3)6-20-2,Shinkawa, Mitaka-shi, Tokyo Japan
Telephone 06-6942-1331
Affiliation 1)Kyoto University Hospital, 2)Osaka National Hospital,3)Kyorin University Hospital 1)Breast Surgery, 2)Department of Surgery (mastology)3)Department of Breast Surgery