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

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 ID
NCT07043725
Phase
PHASE3
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • TQB2102 for injection
  • Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
Locations (sample)
  • Bengbu, Anhui, China|32.94083,117.36083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Quanzhou, Fujian, China|24.91389,118.58583

Key Eligibility Criteria

  • Voluntarily participate in this study, sign the informed consent form, and have good compliance;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months;
  • Histologically or cytologically confirmed HER2-positive invasive breast cancer;
  • Hormone receptor (HR) status confirmed;

For full eligibility, visit ClinicalTrials.gov.

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