drugset / Trial / NCT07342283

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

NCT07342283

Phase 2 Recruiting 30 enrolled Affiliated Hospital of Nantong University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-02-25
Primary completion
2027-12-25
Completion
2028-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject QL1706 Monoclonal antibody 5 mg/kg
Background Carboplatin Small molecule 2 unknown
Background Carboplatin Small molecule 3 unknown
Background Carboplatin Small molecule 5 unknown
Background Cyclophosphamide Other / unclassified 600 mg/m2
Background Doxorubicin Other / unclassified 50 mg/m2
Background Epirubicin Small molecule 90 mg/m2
Background Epirubicin Small molecule 100 mg/m2
Background Paclitaxel Small molecule 125 mg/m2