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A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

StatusRecruiting
PhasePhase 3
Started2025-06-23
View on ClinicalTrials.gov ↗

Amendment history

2025-06-24
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08→confirmed 2025-06-23
Study sitesdetails revised at 25 of 25 sites
2025-06-02
minor
Original filing
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.
Trial Details
NCT Number NCT07003074
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Breast Cancer
Enrollment 642 participants
Start Date 2025-06-23
Primary Completion 2029-07 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2025-06-25