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A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients

Name: A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients — clinical trial record (NCT07824869)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 2

SponsorShanghai Henlius Biotech

Started2026-10-31

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Shanghai Henlius Biotech

56 trials monitored

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Breast Cancer

5,180 trials monitored

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This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).

Trial Details

NCT Number	NCT07824869
Lead Sponsor	Shanghai Henlius Biotech
Conditions	HER2 + Breast Cancer
Enrollment	90 participants
Start Date	2026-10-31
Primary Completion	2028-03-31 (estimated)
Study Completion	2029-12-04 (estimated)
Updated on ClinicalTrials.gov	2026-09-17