breast cancer
Conditions
Interventions
Group 1:PD-1 inhibitor + albumin paclitaxel + bevacizumab (15mg)
Group 2:PD-1 inhibitor + albumin paclitaxel + bevacizumab (7.5mg)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of metastatic or locally advanced unresectable triple negative breast cancer in women aged 18 years and above; 2. The patient had tumor specimens (formalin fixed, paraffin-embedded or fresh pretreated recurrent tumor tissue), which could be used for detection of PD-L1 expression; 3. Neoadjuvant or adjuvant phase radiotherapy and chemotherapy (including the last taxol) were allowed (treatment must be completed at least 12 months prior to randomization of adjuvant or neoadjuvant therapy); 4. Have not received chemotherapy or targeted therapy for advanced breast cancer; 5. There is at least one measurable lesion; 6. ECOG PS: 0-12 points; 7. Predicted survival >=12 weeks; 8. Functional levels of major organs meet the following standards: (1) The standard of blood routine examination shall meet: ANC>=1.5x10^9/L, PLT>=75x10^9/L, Hb>=85g/L (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors); (2) Biochemical examination should meet the following criteria: TBIL =50ml/min (Cockcrod-Gault formula); 9. Patients of childbearing age must already be using reliable contraception or have had a negative pregnancy test (serum or urine) within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration; 10. The patients voluntarily participated in this study with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Untreated central nervous system diseases (active brain metastases (but patients with asymptomatic central nervous system metastases and stable brain metastases after radiotherapy were admitted); 2. A history of autoimmune disease; 3. Acute or chronic active hepatitis B (defined as positive for hepatitis B surface antigen and or hepatitis B core antibody and hepatitis B virus DNA copy number >=1*10E3x10^3 copy number /ml or =200IU/ml) or positive for acute or chronic active hepatitis C antibody. Subjects with hepatitis C antibody positive but RNA negative were admitted to the study group; 4. Have been treated with immune checkpoint inhibitors; 5. Received systemic immune stimulants, systemic glucocorticoids or immunosuppressant therapy in the last 4 weeks; 6. Any serious underlying diseases, comorbidities and active infections; 7. Receiving other anti-tumor treatments; 8. History of epilepsy or seizure induced state; 9. Lactating subjects; 10. Suspected allergy to the drug under study; 11. Other malignancies diagnosed within 5 years, except for non-melanoma skin cancer that was surgically removed, adequately treated cervical carcinoma in situ, locally radical prostate cancer, ductal carcinoma in situ that was surgically radical treated, or malignancies diagnosed more than 2 years ago that had no evidence of disease and had not been treated for less than 2 years before randomization; 12. The investigator determines other conditions that may affect the conduct of clinical studies and the determination of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactShi Yanxia
Sun Yat-sen University Cancer Center
Outcome results
None listed