2018年9月
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: the Japan Breast Cancer Research Group-M05 PRECIOUS study
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
- 巻
- 48
- 号
- 9
- 開始ページ
- 855
- 終了ページ
- 859
- 記述言語
- 英語
- 掲載種別
- 研究論文(学術雑誌)
- DOI
- 10.1093/jjco/hyy097
- 出版者・発行元
- OXFORD UNIV PRESS
The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, openlabel 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.
- リンク情報
- ID情報
-
- DOI : 10.1093/jjco/hyy097
- ISSN : 0368-2811
- eISSN : 1465-3621
- PubMed ID : 30020510
- Web of Science ID : WOS:000442988100011