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A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

StatusRecruiting
PhasePhase 2/3
Started2026-02-27
View on ClinicalTrials.gov ↗

Amendment history

2026-03-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-25→confirmed 2026-02-27
Study sites0→1
2025-12-19
Study Identification, Study Status, Eligibility v1
Eligibility criteria-7,512 characters
Inclusion Criteria: 1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements; 2. Aged ≥ 18 years at the time of signing the ICF, male or [...] one receptor [PgR]) as determined by the central laboratory Note: According to guidelines of American Society of Clinical Oncology and College of American Pathologists, HR-positive is defined as: ER and/or PgR staining in ≥ 1% of tumor cell nuclei; HR-negative is defined a [...] [...]
Study title-45 characters
A Hase II/III Clinical Study to Evaluate HLX22 in Combination With HLX87 as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
2025-12-08
Original filing
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
Trial Details
NCT Number NCT07294508
Lead Sponsor Shanghai Henlius Biotech
Conditions HER2 + Breast Cancer
Enrollment 706 participants
Start Date 2026-02-27
Primary Completion 2028-01-15 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-20