QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer

This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.

Trial Details

NCT ID
NCT07342283
Phase
PHASE2
Sponsor
Affiliated Hospital of Nantong University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Immunotherapy combined with chemotherapy
Locations (sample)
  • Nantong, Jiangsu, China|32.03028,120.87472

Key Eligibility Criteria

  • Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells…
  • Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with tre…
  • Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are …
  • Treatment-naïve subjects;

For full eligibility, visit ClinicalTrials.gov.

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