JBCRG-20 (Neo-peaks)｜Clinical Trials｜Japan Breast Cancer Research Group

JBCRG-20 (Neo-peaks): A randomized, multicenter, phase II trial comparing neo-adjuvant therapy using pertuzumab and trastuzumab emtansine based on the dual HER2 blockade in patients with operable HER2-positive primary breast cancer(Neo-peaks study)

Objectives: To study the best pre-operative therapy using the combination of anti-HER2 monoclonal antibodies in terms of efficacy and safety for patients with HER2-possitive primary breast cancer. To compare the efficacy and safety between two different treatment regimens: docetaxel/carboplatin + trastuzumab + pertuzumab versus docetaxel/carboplatin + trastuzumab + pertuzumab followed by trastuzumab emtansine (T-DM1) + pertuzumab. Additionally, to examine the efficacy and safety of the combination of T-DM1 + pertuzumab, and to evaluate pre-operative anti-HER2 therapy according to response.

Endpoints: Primary： pCR secondary： SpCR, SpCR and ypN0 rate CpCR rate QpCR, QpCR and ypN0 rate Overall response rate (ORR) Breast-conserving surgery rate, and the proportion of breast-conserving surgery rate in patients who planned for mastectomy. The proportion of patients not requiring lymph node dissection. Disease-free survival and Progression-free survival Overall Survival To evaluate the safety profiles of each arm as follows; Adverse events Incidence of cardiac dysfunction

Trial Period: Registration: Aug 2014-Feb 2016
Total study period: Jul 2014-Nov 2016
Post operative follow-up: -Nov 2021 (Follow-up study)

Lead Principal Investigator: Masakazu Toi (Graduate School of Medicine Kyoto University)
Norikazu Masuda (National Hospital Organization Osaka National Hospital)

Conference Presentation: Neoadjuvant therapy with trastuzumab emtansine and pertuzumab in patients with HER2-positive primary breast cancer (A randomized, phase 2 study; JBCRG-20)

Articles and Publications: A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel+carboplatin+trastuzumab+pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer (JBCRG-20 study)

Clinical Trials