At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed HER2-positive invasive breast cancer
- ✓Clinical stage T2-4 with any N, M0, or any T with N1-3, M0
- ✓Hormone receptor status confirmed
- ✓Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy
- ✕Stage IV metastatic breast cancer
- ✕Bilateral breast cancer or inflammatory breast cancer
- ✕History of invasive breast cancer or ductal carcinoma in situ
- ✕Other malignancies within 5 years or currently
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
In Brief
A Phase 3 clinical trial evaluating TQB2102 for injection and Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection for HER2-positive Breast Cancer. Currently recruiting, targeting 544 participants across 78 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
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.