Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer

This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg/kg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg/m2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (m

Trial Details

NCT ID
NCT07017673
Phase
PHASE2
Sponsor
Cedars-Sinai Medical Center
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Ivonescimab
  • Carboplatin
  • Docetaxel
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Pasadena, California, United States|34.14778,-118.14452
  • Torrance, California, United States|33.83585,-118.34063

Key Eligibility Criteria

  • Age ≥ 18 years of age
  • High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO/CAP guidelines
  • Clinically ≥T1cN0, or any T, N1-2
  • Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment

For full eligibility, visit ClinicalTrials.gov.

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