# 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

> **NCT05346224** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Shanghai Henlius Biotech** · enrollment: 900 (estimated)

## Conditions studied

- Breast Cancer
- Breast Neoplasms
- HER2-positive Breast Cancer

## Interventions

- **DRUG:** HLX11
- **DRUG:** EU-Perjeta®

## Key facts

- **NCT ID:** NCT05346224
- **Lead sponsor:** Shanghai Henlius Biotech
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-04-25
- **Primary completion:** 2024-05-15
- **Final completion:** 2025-12-30
- **Target enrollment:** 900 (ESTIMATED)
- **Last updated:** 2025-06-10


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05346224, "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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05346224. Licensed CC0.

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