Advanced, posterior triple negative breast cancer
Conditions
Interventions
Test group:Albumin-paclitaxel combined with subcutaneous injection of PD-L1 monoclonal antibody
Sponsors
Affiliated Cancer Hospital and institute of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18~70 years (including cut-off values), ECOG: 0~1 points, expected survival of more than 3 months. 2. Patients voluntarily agree and have the ability to visit, receive treatment and observe in accordance with the requirements of this protocol, and sign the informed consent form. 3. Patients with histologically confirmed triple negative breast cancer (TNBC). Negative ER and PR are defined as positive for ER<1% and positive for PR<1%. Her-2 negative is defined as immunohistochemistry for Her-2(-) or (1+), where a FISH test must be negative for Her-2 (2+) and a negative result for Her-2 (-) or (1+). 4. Patients who have received 2 or more prior systemic therapies, inoperable, or recurrent/metastatic TNBC (staging according to AJCC 8th edition): 5. Subjects have at least one measurable lesion confirmed by CT or MRI according to the Efficacy Evaluation Criteria for Solid Tumors (RECIST v1.1). Measurable lesions should have not received local therapy such as radiotherapy (lesions located within the area of prior radiotherapy may also be targeted if progression is confirmed). 6. Patients must have adequate organ function (14 days prior to enrollment), i.e., meet relevant laboratory test criteria, defined as follows: a) blood routine (no blood transfusion, no use of hematopoietic stimulating factor, and no use of other drugs to correct blood cell count within 14 days before the first dose): neutrophil count (ANC) = 1.5×109/L; Platelet count (PLT) = 75×109/L; Hemoglobin (HGB) = 9 g/dL. b) Blood biochemistry: serum creatinine (Cr) = 1.5× upper limit of normal (ULN) or creatinine clearance (CCr) = 50 mL/min; Total bilirubin (TBIL) = 1.5× ULN (3×ULN in subjects with Gilbert's syndrome); Alanine aminotransferase [ALT (SGPT)] and aspartate aminotransferase [AST (SGOT)] = 3× ULN (hepatocellular carcinoma, liver metastases = 5×ULN in subjects). c) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) = 1.5×ULN (no correction with anticoagulant drugs or other drugs affecting coagulation function within 14 days before the first dose, except for the situation that long-term use of anticoagulant drugs is required due to the subject's disease). 7.Women of childbearing age are required to use adequate contraception from the time they sign the informed consent form to 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to recombinant anti-PD-1 fully human monoclonal antibody drugs and their components, or to any paclitaxel or nab-paclitaxel components; Those with a history of uncontrolled allergic asthma. 2. Diagnosed with other malignant tumors within 3 years prior to screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, thyroid cancer or cured carcinoma in situ, such as carcinoma in situ of the cervix, etc. 3. Subjects with active autoimmune disease or history of autoimmune disease, with the exception of type I diabetes mellitus that is stable on treatment, well-controlled hypothyroidism that requires only hormone replacement therapy, skin disease that does not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or subjects whose condition is not expected to recur in the absence of external triggers. 4. Have severe cardiovascular disease, such as heart failure graded by the New York Heart Association (NYHA) grade 2 or above, myocardial infarction within 3 months prior to screening, poorly controlled arrhythmia or unstable angina, and severe arterior/venous thrombotic events (such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism, etc.) within 3 months prior to screening. 5. Interstitial lung disease requiring systemic treatment with glucocorticoids. 6. Known central nervous system metastases, meningeal metastases, or treated but still symptomatic central nervous system metastases, meningeal metastases. However, asymptomatic and untreated known central nervous system metastases and meningeal metastases, as well as treated and symptomatic central nervous system metastases and meningeal metastases can be enrolled. 7. Have received any other antibody/drug acting on T cell synergistic stimulation or checkpoint pathway (including but not limited to PD-1, PD-L1, PD-L2, CTLA-4, OX40, C137 inhibitors, etc.). 8. Those who have undergone major surgery within 28 days before the first dose, or have received radiotherapy within 14 days before the first dose, or have used radioactive agents (strontium, samarium, etc.) within 56 days before the first dose. 9. Received systemic anti-tumor therapy within 14 days prior to the first dose. 10. Those who have received live attenuated vaccines within 28 days prior to the first dose or plan to receive a live attenuated vaccine during the study. 11. Active infection requiring intravenous fluid therapy within 14 days prior to the first dose. 12. Receipt of glucocorticoids (prednisone > 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive therapy for a condition within 14 days prior to the first dose. 13. Pregnant or lactating females; or those who have a positive blood pregnancy test in women of childbearing age at screening. 14.Patients who, in the judgment of the investigator, may increase study-related risk, may interfere with the interpretation of study results, or who, in the opinion of the investigator and/or sponsor, are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Security incidents; | — |
Countries
China
Contacts
Public ContactYanfang Zheng
Affiliated Cancer Hospital and institute of Guangzhou Medical University
Outcome results
None listed