RecruitingPhase 2NCT07342283

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


Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called QL1706 to standard chemotherapy before surgery (neoadjuvant therapy) can improve outcomes for people with triple-negative breast cancer — an aggressive subtype that lacks the three main treatment targets (estrogen, progesterone receptors, and HER2). **You may be eligible if...** - You are 18 or older - You have newly diagnosed triple-negative breast cancer (confirmed by biopsy) at clinical stage II or III - Your tumour is at least 2 cm in size, or you have confirmed lymph node involvement - You have not received any prior cancer treatment - You are in good health (ECOG 0–1) with adequate organ function - You are not pregnant and use effective contraception **You may NOT be eligible if...** - You have stage IV (metastatic) breast cancer - You have had chemotherapy, immunotherapy, or radiation in the past 12 months - You have had another invasive cancer in the past 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImmunotherapy 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.


Locations(1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT07342283


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