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A phase 3 trial testing HLX11 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer is a phase 3 interventional study registered as NCT05346224, led by Shanghai Henlius Biotech, and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer. Planned enrolment is 900 participants (estimated). The study started in 2022-04-25 and primary completion is expected in 2024-05-15. No results have been posted on ClinicalTrials.gov.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Shanghai Henlius Biotech, HER2-positive breast cancer.
Shares Shanghai Henlius Biotech, HER2-positive breast cancer.
Shares Shanghai Henlius Biotech, HR-positive / HER2-negative breast cancer.
Shares Shanghai Henlius Biotech, HER2-positive breast cancer.
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