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.
The participant voluntarily joins this study and signs the informed consent form.
Female breast cancer participants aged ≥18 and ≤75 years, with a histologically or cytologically confirmed diagnosis of TNBC (IHC 0, IHC 1+, or IHC 2+/ISH-) based on the most recent biopsy or other pathological specimen, according to the latest ASCO/CAP guidelines. Patients with low ER or PR expression (1%-10%) may also be included in this study.
Patients with high-risk TNBC (defined as lymph node-positive).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism); however, participants with the following conditions are allowed to enroll: vitiligo, psoriasis, alopecia not requiring systemic treatment; well-controlled type I diabetes mellitus; hypothyroidism stable on hormone replacement; childhood asthma that has completely resolved and requires no intervention in adulthood; asthma requiring bronchodilators for medical intervention is excluded.
Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
History of severe hypersensitivity reaction to other monoclonal antibodies.
Prior discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator