Triple-negative breast cancer
Conditions
Interventions
Treatment group:QL1706 (5 mg/kg, Q3W, on day 1) + anlotinib (12 mg each time, QD, on days 1–14, Q3W) + nab-paclitaxel (125 mg/m2, on days 1 and 8, Q3W), with 21 days as one cycle.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The participant voluntarily joins the study, signs the informed consent form, and agrees to strictly comply with all protocol requirements. 2. Female patients aged between 18 and 75 years. 3. Histopathologically confirmed advanced triple-negative invasive breast cancer meeting the following criteria: Triple-negative subtype defined as ER negative (IHC = 6 months. 5. Suitable for treatment with nab-paclitaxel. 6. At least one measurable tumor lesion according to RECIST 1.1 criteria. 7. Life expectancy >= 3 months. 8. ECOG performance status 0 or 1. 9. Adequate organ function, including: (1) Hematology: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count (PLT) >= 100 × 10^9/L; hemoglobin (HB) >= 90 g/L. (2) Liver function: Total bilirubin = 60 mL/min (calculated by the Cockcroft-Gault formula). 10. Female participants of childbearing potential must use adequate contraception during the study and for 120 days after the end of study participation, must have a negative serum pregnancy test within 7 days prior to enrollment, and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1.Known severe allergy to QL1706, anlotinib, nab-paclitaxel, or any of their excipients. 2.Inability to swallow oral medications or presence of any gastrointestinal disease that may interfere with the absorption and metabolism of the study drugs. 3.Symptomatic brain/leptomeningeal metastases and/or spinal cord metastases. 4.Active or potentially relapsing autoimmune disease. The following are excluded: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable doses of hormone replacement therapy; type 1 diabetes mellitus requiring only stable doses of insulin replacement therapy. 5.Major surgery within 3 weeks prior to study start, or failure to recover from surgery. 6.History of organ transplantation, autologous/allogeneic stem cell transplantation. 7.Known or self-reported human immunodeficiency virus (HIV) infection. 8.HBV-DNA positive, HCV-DNA positive (copy number > 10³). 9.Prior treatment with any immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.), or immunocellular therapies, or any other therapies targeting the tumor immune mechanism. 10.Prior treatment with anti-angiogenic targeted therapies. 11.Hypertension that cannot be adequately controlled with a single antihypertensive medication (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 90 mmHg). 12.History of arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to enrollment. 13.Presence of other malignancies within 5 years prior to enrollment, except for TNBC. 14.Tumor invasion or compression of surrounding major blood vessels or organs. 15.Active central nervous system (CNS) metastatic lesions. 16.Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 17.History of myocarditis, cardiomyopathy, or malignant arrhythmias. 18.History of severe bleeding tendency or coagulation dysfunction. 19.History of esophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to first dose. 20.Known active tuberculosis (TB). 21.Current or prior history of non-infectious pneumonitis/interstitial lung disease requiring systemic corticosteroid therapy. 22.Major surgery or severe trauma within 30 days prior to first dose, or planned major surgery within 30 days after first dose; minor local surgery within 3 days prior to first dose. 23.Platelet or red blood cell transfusion within 4 weeks prior to start of study drug treatment. 24.Receipt of live vaccine within 4 weeks prior to first dose, or planned receipt of live vaccine during the study period. 25.Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period. 26.Patients deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Safety Outcomes (including Adverse Events [AE], Treatment-Emergent Adverse Events [TEAE], Severity Grade of Serious Adverse Events [SAE], Incidence, Severity, and Relationship to Investigational Drug); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DoR);12-Month Progression-Free Survival Rate;12- or 24-Month Overall Survival Rate;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactZhang Lili, Yuan Yuan
Jiangsu Cancer Hospital
Outcome results
None listed