NCT07342283

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	Immunotherapy combined with chemotherapy	Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.

Timeline

• Start date: 2026-02-25
• Primary completion: 2027-12-25
• Completion: 2028-12-25
• First posted: 2026-01-15
• Last updated: 2026-03-02

Locations

1 site across 1 country: China