JBCRG-10｜Clinical Trials｜Japan Breast Cancer Research Group

JBCRG-10: A randomized phase II comparative study of preoperative chemotherapies including Trastuzumab + Cyclophosphamide + Docetaxel for operable HER2 positive breast cancer

Objectives: To compare the efficacy and safety of FEC followed by TCH, TCH followed by FEC, and therapy without anthracyclines, with the aim of improving the pathological complete response (pCR) rate by preoperative chemotherapy for operable HER2 positive breast cancer

Endpoints: Primary endpoint:Pathological complete response, Secondary endpoints: Safety, incidence of cardiac disorders, clinical response rate, overall survival, breast conservation rate and rate without axillary lymph node dissection

Trial Period: Registration: 2 years (Sep 2009-Dec 2011)
Follow-up: 3 years (Jan 2012-Aug 2014)

Lead Principal Investigator: Masakazu Toi(Department of Surgery, Breast Surgery, Graduate School of Kyoto University)
Norikazu Masuda(Department of Surgery, Osaka National Hospital)
Takayuki Ueno(Dept of Breast Surgery, Kyoto University Hospital)

Conference Presentation: Inter-observer concordance of Ki-67 labeling index inbreast cancer[br]: Japan Breast Cancer Research Group (JBCRG) Ki-67 Ring Study A Prospective Multicenter Randomized Phase II Neo-Adjuvant Study of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Docetaxel, Cyclophosphamide and Trastuzumab (TCH) Versus TCH Followed by FEC Versus TCH Alone, in Patients (pts) with Operable HER2 Positive Breast Cancer: JBCRG-10 Study A multicenter, randomized phase II study of neoadjuvant chemotherapy including trastuzumab with cyclophosphamide with docetaxel in patients with operable HER2-positive breast cancer (JBCRG-10 study).

Articles and Publications: Multicenter study of primary systemic therapy with docetaxel, cyclophosphamide and trastuzumab for HER2-positive operable breast cancer: the JBCRG-10 study

Clinical Trials