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A randomized, multicenter, open-label, phase II/III trial comparing ARX788 vs Lapatinib and Capecitabine in patients with HER2-positive locally advanced or metastatic breast cancer

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Trial Profile

A randomized, multicenter, open-label, phase II/III trial comparing ARX788 vs Lapatinib and Capecitabine in patients with HER2-positive locally advanced or metastatic breast cancer

Status: Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Jan 2021

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At a glance

  • Drugs ARX 788 (Primary) ; Capecitabine; Lapatinib
  • Indications Advanced breast cancer
  • Focus Therapeutic Use
  • Acronyms ZMC-ARX788-211

    • Most Recent Events

    • 25 Jan 2021 New trial record
    • 11 Dec 2020 1st interim analysis will be performed when 160 patients have completed Cycle 4 assessment to detect potential early futility trends. The 2nd interim analysis will be performed when 2/3 of the IRC assessed PFS events have occurred, in which early superiority will be declared if the P-value crossed the O Brien Fleming boundary, and sample size will be recalculated if the conditional power is promising but below 80% as per trial design presented at the 43rd Annual San Antonio Breast Cancer Symposi

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