Triple-negative Breast Cancer
Conditions
Interventions
experimental group:PD-1 monoclonal antibody plus anlotinib combined with metronomic chemotherapy
Sponsors
The Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Female patients with triple-negative breast cancer who cannot be resected or recurred/metastasis confirmed by histology or pathology 2) Patients who have previously received treatment within 2 lines 3) 18-75 years old; 4) ECOG physical status: 0-2 points; 5) The expected survival period is more than 3 months; 6) The main organs function normally, that is, they meet the following standards: a) Routine blood examination: i. Hemoglobin (HB) >= 90 g/L (no blood transfusion or blood products, no hematopoietic stimulating factor used within 14 days); ii. Absolute centriocyte (ANC) >= 1.5 x 10^9 /L; iii. Platelets (PLT) >= 75 x 10^9/L; b) Biochemical examination: i. Albumin (ALB) >= 28 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x ULN; iii. Total bilirubin TBIL <= 2 x ULN; iv. Serum creatinine (Cr) <= 1 x ULN; 7)Women should agree to use contraceptive measures (such as intrauterine device [IUD], contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before study entry was negative, and must be non-lactating; 8)The patient has at least one measurable lesion (RECIST 1.1); 9) Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1) Suffered from other malignant tumors in the past or at the same time; 2) Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 3) Patients who have previously received VEGFR target inhibitor drugs including Anlotinib hydrochloride capsules, or have used other PD-1/PD-L1/PD-L2 /CTLA-4 Antibody therapy or other immunotherapy against PD-1/PD-L1/PD-L2/CTLA-4; 4) Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 5) History of gastrointestinal bleeding caused by severe gastroesophageal varices or clear gastrointestinal bleeding tendency; or clear gastrointestinal bleeding tendency due to other reasons, such as active ulcer, ulcerative colitis, etc.; stool Occult blood++ or above; 6) Any of the following coagulation abnormalities: prothrombin time (PT) > 16 s, activated partial thromboplastin time (APTT) > 48 s, thrombin time (TT)> 21 s, INR > 2, fibrinogen (FIB) = 150 mmHg or diastolic blood pressure >= 100 mmHg); b) Patients with grade I or higher myocardial ischemia or Myocardial infarction, arrhythmia (including QTc >= 480ms) and congestive heart failure >= 2 grade (New York Heart Association (NYHA) classification); LVEF (left ventricular ejection fraction) 10 mmol/L); e) Renal failure requires hemodialysis or peritoneal dialysis; f) Urine routine reminder Urinary protein >= ++, and confirmed 24-hour urine protein quantification > 1.0 g; g) HIV test positive; h) HBV-DNA > 2500 IU/ml. 8) In the 4 weeks before enrollment, any bleeding or bleeding event >= CTC AE level 3 , unhealed wounds, ulcers or fractures; 9) Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 10) There is any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; subjects need bronchodilators for medical treatment Interventional asthma cannot be included); but the following patients are allowed to be included in the group: vitiligo, psoriasis, alopecia without systemic treatment, well-controlled type I diabetes, and hypothyroidism with normal thyroid function after replacement therapy; 11) Subjects with symptomatic central nervous system (CNS) diseases and / or cancerous meningitis and leptomeningeal diseases; (unless asymptomatic, or treated and stable, no imaging evidence of new brain metastasis or expansion of brain metastasis was found at least 2 weeks after brain metastasis treatment, and steroid or anticonvulsant treatment was stopped for at least 14 days before the start of study treatment. If the subject was found to have active or new untreated and asymptomatic CNS metastasis during the screening period, it must be Imaging evidence of new brain metastasis or expansion of brain metastasis after radiotherapy or no treatment for at least 2 weeks.) 12) According to th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate;Adverse Event;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Overall survival;Clinical benefit rate; | — |
Countries
China
Contacts
Public ContactHuihui Li
The Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed