breast cancer
Conditions
Interventions
Camrelizumab + Anlotinib Hydrochloride + Albumin Paclitaxel:Camrelizumab + Anlotinib Hydrochloride + Albumin Paclitaxel
Sponsors
Affiliated Cancer Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female aged 18-75 years old. 2.ECOG 0 or 1 point. 3.Advanced triple-negative invasive breast cancer confirmed by histopathological examination, and meet the following conditions at the same time: 1)The pathological classification is triple negative, specifically: ER negative: IHC=6 months from the end of treatment to enrollment. 5.At least one objectively measurable lesion (extracranial) according to the RECIST 1.1. 6.Patients with central nervous system (CNS) metastases should have an expected survival period of >=6 months, stable metastatic disease and no obvious symptoms 7.The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements: 1)Routine blood test (without blood transfusion within 14 days): a.Hemoglobin (HB)>=90 g/L; b.Neutrophil count (ANC)>=.5×10^9/L; c.Platelet count (PLT) >=100×10^9/L; 2)Biochemical test: a.Total bilirubin=60mL/min (Cockcroft-Gault formula). 8.Female patients of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result must be negative. Female patients of childbearing age must agree to use high-efficiency methods of contraception during the study period and within 180 days after the last administration of the study drug. 9.Volunteer to participate in this study, sign an informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1.Female who are pregnant, lactating or planning to become pregnant during the study period; 2.Known allergy to any drug in the study; 3.Patients who have previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or anti-vascular targeted therapy; 4.Patients with central nervous system (CNS) metastases who are judged to have rapid progression of metastases(or with obvious symptoms); 5.Concomitant diseases/history: 1)Patients with any known or suspected autoimmune disease, except: autoimmune thyroiditis and type I diabetes patients with stable blood sugar control; 2)Patients with hypertension who cannot be well controlled by single antihypertensive drug treatment (systolic blood pressure >=150 mmHg, diastolic blood pressure >=90 mmHg); 3)Peripheral neuropathy >= grade 2; 4)Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male>= 450 ms) requires long-term antiarrhythmic use Drugs and >= grade II (New York Heart Association classification) cardiac insufficiency; 5)Active or uncontrolled serious infection (>=NCI CTCAE V5.0 grade 2 infection); 6)A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 7)Patients with active hepatitis B or C (serum HBsAg and HBcAb positive, HBeAg or HBeAb positive for hepatitis B; HCV-Ab positive for hepatitis C); 8)A history of interstitial lung disease and non-infectious pneumonia requiring steroid treatment; 9)A history of active tuberculosis; 10)The urine routine test indicates that the urine protein is >=++, and the 24-hour urine protein quantitative is >1.0g; 11)Suffered from other malignant tumors within 5 years before enrollment, except for malignant tumors that have been cured or have stable disease; 12)Unrelieved toxic reactions higher than grade 2 or above (NCI CTCAE V5.0) due to any previous treatment, excluding alopecia; 13)Patients with multiple factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 14)Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg= grade 3 (NCI CTCAE V5.0), unhealed wounds, ulcers or fractures; 19)Those who have experienced arterial/venous thrombotic events before enrollment or within 6 months, such as cerebrovascular event(including temporary ischemic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;Safety; | — |
Countries
China
Contacts
Public ContactZhao Bing
Affiliated Cancer Hospital of Xinjiang Medical University
Outcome results
None listed