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Clinical trial

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

NCT03500380 is registered in ClinicalTrials.gov with RemeGen Co., Ltd. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
RemeGen Co., Ltd.
Phase
Phase 2/3
Overall status
Unknown status
Start date
April 24, 2018
Completion date
December 31, 2024
Enrollment
301 (estimated)
Sites
67

Conditions

As the registry lists them; a condition with its own page is linked.

breast diseases, breast neoplasms, capecitabine, her2 positive breast carcinoma, her2-positive advanced breast with liver metastases, her2-positive breast cancer