Clinical Trial

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer

Name: A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer — clinical trial record (NCT07601620)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Not Yet Recruiting Phase 1

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Summary

This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .

Trial Details

NCT Number	NCT07601620
Lead Sponsor	Shanghai Henlius Biotech
Conditions	HER2 + Breast Cancer
Enrollment	258 participants
Start Date	2026-07-03
Primary Completion	2027-04-23 (estimated)
Study Completion	2027-07-22 (estimated)
Updated on ClinicalTrials.gov	2026-05-22