論文

査読有り
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
  • Yutaka Yamamoto
  • Hiroji Iwata
  • Takayuki Ueno
  • Naruto Taira
  • Masahiro Kashiwaba
  • Masato Takahashi
  • Hiroshi Tada
  • Koichiro Tsugawa
  • Tatsuya Toyama
  • Naoki Niikura
  • Fumikata Hara
  • Tomomi Fujisawa
  • Tetsuhiro Yoshinami
  • Shigehira Saji
  • Toshimi Takano
  • Norikazu Masuda
  • Satoshi Morita
  • Masakazu Toi
  • Shinji Ohno
  • 全て表示

48
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
DOI
https://doi.org/10.1093/jjco/hyy097
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/30020510
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000442988100011&DestApp=WOS_CPL
ID情報
  • DOI : 10.1093/jjco/hyy097
  • ISSN : 0368-2811
  • eISSN : 1465-3621
  • PubMed ID : 30020510
  • Web of Science ID : WOS:000442988100011

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