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Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.

ABSTRACT: PURPOSE:The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer. METHODS:Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included objective response rate (in patients with measurable baseline disease), overall survival, and safety. The consistency threshold for PFS (hazard ratio [HR]?

SUBMITTER: Xu B 

PROVIDER: S-EPMC7320929 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.

Xu Binghe B   Li Wei W   Zhang Qingyuan Q   Shao Zhimin Z   Li Qiao Q   Wang Xiaojia X   Li Huiping H   Sun Tao T   Yin Yongmei Y   Zheng Hong H   Feng Jifeng J   Zhang Hong H   Lei Guiyuan G   Restuccia Eleonora E  

Breast cancer research and treatment 20200620 3

<h4>Purpose</h4>The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer.<h4>Methods</h4>Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed pro  ...[more]

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