triple negative breast cancer
Conditions
Interventions
Experimental group:albumin bound paclitaxel+SintilimAb+capecitabine
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Histopathologically confirmed triple negative breast cancer; 3. The patient understands and voluntarily signs the informed consent to enter the group treatment; 4. The expected survival time is greater than 12 weeks; 5. ECOG status score is 0-2 points; 6. At least one measurable lesion according to mRECIST criteria; 7. The level of organ function must meet the following requirements: (1) Hematological indicators: absolute neutrophil count >=1.5x10^9/L, platelet count >=80x10^9/L, hemoglobin >= 9.0 g/dL (can be maintained by blood transfusion); (2) Liver function: total bilirubin = 50ml/min. 8. Women of childbearing age must take a urine pregnancy test within 7 days before starting treatment and the result is negative, and they are not breastfeeding, and men must agree to use appropriate methods of contraception or surgery during the trial and within 8 weeks after the last administration of the trial drug sterilization; 9. Disease progression during the previous anthracycline rescue therapy (complete at least two cycles), ineffective neoadjuvant therapy or metastasis within 12 months after the end of adjuvant therapy; 10. The past medication history of capecitabine and taxanes meets one of the following conditions: (1) Have not used capecitabine/taxane before; (2) Have not used capecitabine/taxane in the past; (3) Standard use of capecitabine/taxane in the treatment of advanced breast cancer and no progression within 6 months of treatment, and no use of capecitabine/taxane within 6 months before the first dose ( Note: Standard use of capecitabine/taxane is defined as at least 2 cycles according to the instructions of capecitabine/taxane). 11. Good compliance, voluntary follow-up, treatment, laboratory examination, follow-up and other research procedures as planned.
Exclusion criteria
Exclusion criteria: 1. BRCA gene mutation; 2. The patient has any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism Wait; 3. Received radiotherapy within 4 weeks before enrollment, or received radiopharmaceutical treatment within 8 weeks; 4. Have undergone major surgery within 4 weeks before enrollment or have not fully recovered from the previous surgery (the definition of major surgery refers to the level 3 in the "Administrative Measures for the Clinical Application of Medical Technology" implemented on May 1, 2009. and level 4 surgery); 5. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment; 6. Have used anti-PD-1, PD-L1 or another drug that directly acts on T cell surface inhibitory receptors (such as CTLA-4, OX-40, CD137); 7. Other malignant tumors in the past 5 years, excluding cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer or surgically resected breast duct carcinoma in situ; 8. Those who have a history of psychotropic drug abuse and cannot be relieved or have mental disorders; 9. The patient has one or more of the following conditions: (1) Patients with symptomatic central nervous system metastasis or spinal cord compression; (2) massive pleural effusion or pericardial effusion; (3) Any unstable systemic disease (including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease, and resistant hypertension, liver, kidney or metabolic disease) ; (4) Existing severe acute infection that has not been controlled; or those who have purulent and chronic infection, and the wound does not heal; (5) Those with bleeding tendency; (6) HIV positive; (7) BsAg positive and HBV DNA copy number positive; (8) Positive HCV antibody in the blood screening for chronic hepatitis C. 10. Allergic constitution or multiple drug allergy or allergic or intolerant to PD-1, albumin-bound paclitaxel, capecitabine; 11. Patients who use drugs or alcohol for a long time, which affects the evaluation of the test results; 12. Metastatic lesions need local treatment at the same time, such as TACE for liver metastases, radiotherapy for lung metastases, etc.; 13. In the opinion of the investigator, the subject may not be able to complete the study or may not be able to comply with the requirements of the study (for administrative reasons or otherwise).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion; | — |
Countries
China
Contacts
Public ContactZeng Qingan
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed