# 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

Source: https://onco.cc/trials/nct05346224/  
OnCo record `nct05346224` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing HLX11 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.

## Summary

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT05346224
- Phase: 3
- Setting: A Multicenter, Randomized, 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
- Sponsor: Shanghai Henlius Biotech
- Enrolled: 900

## Sources

- ClinicalTrials.gov NCT05346224: https://clinicaltrials.gov/study/NCT05346224

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [HLX11](https://onco.cc/drugs/hlx11/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)

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