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 s

Abstract:

: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.

journal_name

Jpn J Clin Oncol

authors

Yamamoto Y,Iwata H,Ueno T,Taira N,Kashiwaba M,Takahashi M,Tada H,Tsugawa K,Toyama T,Niikura N,Hara F,Fujisawa T,Yoshinami T,Saji S,Takano T,Masuda N,Morita S,Toi M,Ohno S

doi

10.1093/jjco/hyy097

subject

Has Abstract

pub_date

2018-09-01 00:00:00

pages

855-859

issue

9

eissn

0368-2811

issn

1465-3621

pii

5055436

journal_volume

48

pub_type

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