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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study ID
NCT07043725
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB2102 for injection — DRUG
    TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
  • Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection — DRUG
    TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.

Study Details

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.

Key Dates

First listed
Jun 29, 2025
Start date
Sep 15, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
544 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2102 for injection
    6mg/kg TQB2102 for injection, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 8 cycles.
  • Active Comparator: Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
    Trastuzumab injection (The first dose is 8mg/kg, followed by 6mg/kg), Pertuzumab Injection (The first dose is 840, followed by 420mg), Docetaxel Injection (75mg/m2 ) combined with Carboplatin Injection (AUC-6, 800 mg max), Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6 cycles.

Primary Outcome Measure

Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) [ Time Frame: Up to 26 months after study start ]

Central Contacts

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