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Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

StatusRecruiting
PhasePhase 3
Started2025-07-07
View on ClinicalTrials.gov ↗

Amendment history

2025-08-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06→confirmed 2025-07-07
Study sitesdetails revised at 31 of 31 sites
2025-05-30
Original filing
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
Trial Details
NCT Number NCT07008976
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Metastatic Breast Cancer
Enrollment 246 participants
Start Date 2025-07-07
Primary Completion 2028-03 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-14