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A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

StatusRecruiting
PhasePhase 3
Started2025-09-15
View on ClinicalTrials.gov ↗

Amendment history

2026-03-26
minor
Study Status, Contacts/Locations v4
Study sites77→78
2025-09-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-09-15
Study sitesdetails revised at 77 of 77 sites
2025-09-03
minor
Study Status, Study Design, Contacts/Locations v2
Start date2025-08→2025-09
Enrollment target792→544
Study sites71→77
2025-06-30
minor
Study Status, Arms and Interventions v1
InterventionsTQB2102 for injection (Drug), Trastuzumab injection+ Pertuzumab Injection + Docetaxel Injection + Carboplatin Injection (Drug)→TQB2102 for injection (Drug), Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection (Drug)
2025-06-20
minor
Original filing
This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.
Trial Details
NCT Number NCT07043725
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions HER2-positive Breast Cancer
Enrollment 544 participants
Start Date 2025-09-15
Primary Completion 2027-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-27