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A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases

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Trial Profile

A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Disitamab vedotin (Primary) ; Capecitabine; Lapatinib
  • Indications Advanced breast cancer; HER2 positive breast cancer; Liver metastases; Male breast cancer
  • Focus Therapeutic Use
  • Sponsors RemeGen

Most Recent Events

  • 12 Dec 2024 Results (As of data cutoff date December 31, 2023) presented in the RemeGen Media Release.
  • 18 Feb 2024 Planned primary completion date changed from 31 Dec 2023 to 31 Jul 2024.
  • 23 Nov 2023 Planned End Date changed from 31 Dec 2023 to 31 Dec 2024.

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