Patients with triple-negative breast cancer who have lymph node metastasis after surgery
Conditions
Interventions
Intervention group:QL1706
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily joined this study and signed the informed consent form. 2. Female breast cancer participants aged 18 years or older and 75 years or younger, who are in accordance with the latest ASCO/CAP guidelines and based on the most recent biopsy or other pathological specimens, are diagnosed with TNBC (IHC 0, IHC 1+ or IHC 2+/ISH-) through histological or cytological examination, and have low expression of ER or PR (1% - 10%), can also be included in this study. 3. High-risk TNBC patients (defined as those with positive lymph nodes); 4. The Eastern Cooperative Oncology Group (ECOG) performance status score (PS) was 0 or 1; 5. Agree to provide the pathological samples of the tumor tissues obtained during the surgery (FFPE, at least 5 sections) for biological sample testing; 6. Expected survival period >= 3 months; 7. The functions of important organs should meet the following requirements (no blood components or cell growth factor drugs should be used within 14 days before the first administration): (1) Absolute neutrophil count >=1.5×10^9/L; (2) Platelets >=100×10^9/L; (3) Hemoglobin >=90 g/L; (4) Serum albumin >=30 g/L; (5) Thyroid-stimulating hormone (TSH) <=1×ULN (if abnormal, FT3 and FT4 levels should also be considered; if FT3 and FT4 are normal, the patient can be enrolled); (6) Serum total bilirubin <=1.5×ULN; (7) ALT and AST <=2.5×ULN, if liver metastasis is present, ALT and AST <=5×ULN; (8) AKP <=2.5×ULN (for liver or bone metastasis, AKP <=5×ULN); (9) Serum creatinine <=1.5×ULN; (10) International Normalized Ratio (INR) <=1.5×ULN (without anticoagulant therapy); 8. For patients undergoing non-surgical sterilization or those of childbearing age, during the study treatment period and within 3 months after the end of the study treatment, they are required to use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms); for non-surgical sterilized patients of childbearing age, the serum or urine HCG test must be negative 7 days before the first medication; and they must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. There is any active autoimmune disease or a history of autoimmune disease (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; but the following participants are allowed to be enrolled: vitiligo, psoriasis, alopecia that does not require systemic treatment, well-controlled type 1 diabetes, hypothyroidism with normal thyroid function after replacement therapy; patients who have completely recovered from childhood asthma and do not require any intervention after adulthood; asthma that requires medical intervention with bronchodilators cannot be included). 2. Those who are currently using immunosuppressants or systemic hormones to achieve immunosuppressive effects (with a dose of more than 10 mg/day of prednisone or other hormones with equivalent efficacy), and who are still continuing to use them within 2 weeks prior to enrollment; 3. Had severe allergic reactions to other monoclonal antibodies; 4. Those who discontinued the treatment during anti-PD-1/PD-L1 antibody therapy due to related toxicities; 5. It is known that there is a history or evidence of interstitial lung disease or active non-infectious pneumonia. 6. The patient has a history of CNS metastasis or currently has a CNS metastatic lesion. There is no mandatory requirement for a baseline scan to confirm the presence of brain metastases. If the status of CNS metastasis is unknown but there are any clinical signs suggesting CNS metastasis, and the presence of CNS metastasis can be ruled out through CT and/or MRI scans, then the patient is eligible to participate in the study; 7. Patients who have previously suffered from other malignant tumors (except for those with non-melanoma skin cancer or cervical carcinoma in situ who are eligible, patients with other previous malignant tumors must have at least 3 years of disease-free period); 8. Has hypertension and the condition remains uncontrolled despite treatment with antihypertensive drugs (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); It is allowed to achieve the above parameters through the use of antihypertensive treatment; Has previously experienced hypertensive crisis or hypertensive encephalopathy; 9. Within 6 months prior to the first administration, there is a known history of unstable angina pectoris, myocardial infarction (MI), or chronic heart failure (CHF), or a known history of clinically significant arrhythmia requiring anti-arrhythmic treatment (except for stable atrial fibrillation) or a left ventricular ejection fraction of less than 50%. 10. Patients who are currently undergoing thrombolytic or anticoagulant therapy are permitted to receive prophylactic use of low-dose aspirin and low-molecular-weight heparin. 11. If the patient has pleural effusion, ascites or pericardial effusion that requires drainage, and if the symptoms stabilize after the drainage procedure, the patient can be included in the study. 12. Events of thrombosis in the blood vessels (either arteries or veins) that occurred within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc. 13. Having suffered from a major vascular disease within the six months prior to the start of the treatment (for instance, requiring surgical repair or having recently developed pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;Overall survival period;The incidence and severity of adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TRAEs), as well as abnormal values of laboratory indicators, are evaluated accord;3-year distant disease-free survival rate; | — |
Countries
China
Contacts
Public ContactXiaoan Liu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed