A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 cycle 9, participants will receive QL1706 monotherapy as maintenance treatment. Dosing will continue until protocol-defined treatment discontinuation criteria are met, the participant experiences intolerable toxicity, or the participant withdraws informed consent. The maximum number of QL1706 dosing cycles is 17. After completing treatment, participants will continue to undergo post-treatment safety follow-up and survival follow-up. For participants who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted after treatment ends. After enrollment, safety assessments will be performed every 3 weeks, and imaging evaluations will be performed every 12 weeks (±7 days) until confirmed disease progression per RECIST v1.1, initiation of another new anti-cancer therapy, withdrawal of informed consent, or death, whichever occurs first.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobrowolny udział w badaniu i podpisanie zgody.
- •Kobieta w wieku 18-75 lat z rakiem piersi potwierdzonym badaniem mikroskopowym, bez receptorów hormonalnych (lub bardzo niskie ich stężenie).
- •Nowotwór z przerzutami do węzłów chłonnych.
- •Stan ogólny pacjenta (ECOG) 0 lub 1 — pacjent sprawny, z minimalnym ograniczeniem aktywności.
- •Gotowość do dostarczenia próbki nowotworu do badania markerów biologicznych.
- •Oczekiwana przeżywalność co najmniej 3 miesiące.
- •Prawidłowe wyniki parametrów krwi: liczba neutrofili ≥1,5×10⁹/L, płytki ≥100×10⁹/L, hemoglobina ≥90 g/L, albumina ≥30 g/L.
- •Kobiety w wieku rozrodczym muszą stosować antykoncepcję przez leczenie i 3 miesiące po jego zakończeniu; test ciążowy musi być ujemny.
✗ Disqualifies
- •Aktywna choroba autoimmunologiczna lub historia choroby autoimmunologicznej (np. zapalenie wątroby, zapalenie płuc, zapalenie oka, zapalenie jelit, zapalenie podwzgórza, zapalenie naczyń, zapalenie nerek, nadczynność tarczycy).
- •Aktualnie przyjmowanie leków immunosupresyjnych lub kortykosteroidów (dawka >10 mg na dzień prednizonu) w ciągu 2 tygodni przed włączeniem do badania.
- •Historia ciężkiej alergii na przeciwciała monoklonalne.
- •Wcześniejsze przerwanie leczenia inhibitorami PD-1/PD-L1.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- June 3, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Trial contact
Xiaoan Liu
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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