TY - JOUR
T1 - A randomized, open-label, phase III trial of pertuzumab retreatment in HER2-positive locally advanced/metastatic Breast cancer patients previously treated with pertuzumab, trastuzumab and chemotherapy
T2 - The Japan Breast cancer research group-M05 PRECIOUS study
AU - Yamamoto, Yutaka
AU - Iwata, Hiroji
AU - Ueno, Takayuki
AU - Taira, Naruto
AU - Kashiwaba, Masahiro
AU - Takahashi, Masato
AU - Tada, Hiroshi
AU - Tsugawa, Koichiro
AU - Toyama, Tatsuya
AU - Niikura, Naoki
AU - Hara, Fumikata
AU - Fujisawa, Tomomi
AU - Yoshinami, Tetsuhiro
AU - Saji, Shigehira
AU - Takano, Toshimi
AU - Masuda, Norikazu
AU - Morita, Satoshi
AU - Toi, Masakazu
AU - Ohno, Shinji
N1 - Funding Information:
This work is supported by Chugai Pharmaceutical Co., Ltd through a contract with the Japan Breast Cancer Research Group (JBCRG), which is the study operation organization. Each participating sites receives a research fund from the JBCRG. Chugai Pharmaceutical Co., Ltd is involved in the provision of information relating to the study, but not in the conduct of the study, or the analysis and interpretation of study results.
Publisher Copyright:
© The Author(s) 2018.
PY - 2018/9/1
Y1 - 2018/9/1
N2 - The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label Phase III study to determine if retreatment with pertuzumab is more effective than conventional treatment in HER2-positive locally advanced (LA)/metastatic Breast cancer (MBC) patients previously treated with pertuzumab, trastuzumab and chemotherapy. Patients are randomized 1:1 into chemotherapy plus trastuzumab with or without pertuzumab groups. The latest regimen before enrollment did not include pertuzumab, and the number of previous chemotherapy regimens for LA/MBC did not exceed three. The primary endpoint is investigator-assessed progression-free survival. Secondary endpoints include independent reviewer-assessed progression-free survival, progression-free survival in patients treated with trastuzumab emtansine as the latest regimen, response rate, response duration, overall survival, safety and health-related quality of life. Target accrual is 370 patients, allowing the observation of 325 events, yielding an 80% power for detection of a hazard ratio of 0.739 with a one-sided 5% level of significance.
AB - The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label Phase III study to determine if retreatment with pertuzumab is more effective than conventional treatment in HER2-positive locally advanced (LA)/metastatic Breast cancer (MBC) patients previously treated with pertuzumab, trastuzumab and chemotherapy. Patients are randomized 1:1 into chemotherapy plus trastuzumab with or without pertuzumab groups. The latest regimen before enrollment did not include pertuzumab, and the number of previous chemotherapy regimens for LA/MBC did not exceed three. The primary endpoint is investigator-assessed progression-free survival. Secondary endpoints include independent reviewer-assessed progression-free survival, progression-free survival in patients treated with trastuzumab emtansine as the latest regimen, response rate, response duration, overall survival, safety and health-related quality of life. Target accrual is 370 patients, allowing the observation of 325 events, yielding an 80% power for detection of a hazard ratio of 0.739 with a one-sided 5% level of significance.
KW - Breast cancer
KW - Pertuzumab
KW - Retreatment
UR - http://www.scopus.com/inward/record.url?scp=85054063181&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85054063181&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyy097
DO - 10.1093/jjco/hyy097
M3 - Article
C2 - 30020510
AN - SCOPUS:85054063181
SN - 0368-2811
VL - 48
SP - 855
EP - 859
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
IS - 9
ER -
