A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.

This study is a prospective, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of postoperative chemotherapy combined with QL1706 in patients with high-risk triple-negative breast cancer. After enrollment, participants will receive 8 cycles of chemotherapy combined with QL1706. The standard chemotherapy regimen is the AC-T regimen (4 cycles of epirubicin plus cyclophosphamide, followed by 4 cycles of a taxane) - a Category I recommendation in the 2025 CSCO guidelines. The final choice of chemotherapy regimen is at the investigator's discretion. Starting from cy

Trial Details

NCT ID
NCT07622836
Phase
NA
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Aipaluoli-tovorilimab plus AC-T chemotherapy as postoperative adjuvant therapy
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • The participant voluntarily joins this study and signs the informed consent form.
  • Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC…
  • Patients with high-risk TNBC (defined as lymph node-positive).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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