Breast cancer
Conditions
Interventions
Experimental group:AK105 + Anlotinib Hydrochloride + Albumin Paclitaxel
Sponsors
Liaoning Tumor Hospital & Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Females aged 18-75 years when signing the informed consent; 2. ECOG score of 0 or 1; 3. Advanced triple-negative invasive breast cancer confirmed by histopathological test, and meet the following conditions: (1) The pathological type is triple negative, specifically: ER negative: IHC=6 months (Among them, the enrollment ratio of patients with a time of 6-12 months from the end of treatment to the enrollment should be less than 30% of the total enrollment, that is, = 90g/L, neutrophil count (ANC) >= 1.5x10^9/L, platelet count (PLT)>=100x10^9/L; (2) Biochemical tests: total bilirubin = 60 mL/min (Cockcroft-Gault formula); 7. Women of childbearing age must undergo a serum pregnancy test within 3 days before the first dose, and the result is negative. Female subjects of reproductive age must agree to use a highly effective method of contraception during the study and for 180 days after the last dose of study drug; 8. Voluntarily participate in this study, sign the informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. Female patients 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 received PD-1/PD-L1 antibody, CTLA-4 antibody, or anti-vascular targeted therapy in the past; 4. Patients with central nervous system (CNS) metastases (or with obvious symptoms) who are judged to have rapid progression of metastases; 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) Those with a history of unstable angina pectoris; those newly diagnosed with angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: male >= 450 ms) requires long-term use of antiarrhythmic drugs and New York Heart Association class >= II cardiac insufficiency; (5) Active or uncontrolled serious infection (>=NCI CTCAE V5.0 grade 2 infection); (6) Those with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (7) Patients with active hepatitis B or C; (8) Past interstitial lung disease and non-infectious pneumonia requiring steroid treatment; (9) Those with a history of active tuberculosis; (10) The urine routine indicates that the urine protein is >=++, and it is confirmed that the 24-hour urine protein quantification is greater than 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 NCI CTCAE V5.0 grade 2 or above due to any previous treatment, excluding alopecia; (13) Those 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=NCI CTCAE V5.0 grade 3 within 4 weeks before enrollment, with unhealed wounds, ulcers or fractures ; (19) Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactSun Tao
Liaoning Tumor Hospital & Institute
Outcome results
None listed