Triple negative breast cancer
Conditions
Interventions
experimental group:Anlotinib+nab-paclitaxel+carboplatin
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet all of the following criteria: 1.Sign informed consent before implementing any trial-related procedures; 2.Aged 18-75 years, female; 3.Patients with primary invasive triple-negative breast cancer diagnosed by pathology; 4.Stage II-III; 5.Patient's ECOG physical status score is 0-1; 6.Have not received any anti-tumor treatment (including any form of chemotherapy, radiotherapy, and Chinese medicine treatment) within at least one month before treatment; 7.Demonstrates adequate organ function: (1)Patients did not receive blood, platelet transfusion or growth factor support treatment within 14 days before blood sample collection in the screening period, and needed to meet: a.Hemoglobin(HB)>= 9g / dL; b.The absolute value of neutrophil(ANC)>= 1.5 x 10^9/L; c.Platelets(PLT)>= 100 x 10^9/L; (2)The biochemical inspection must meet the following indicators: a.Serum creatinine(Cr)= 60mL / min; b.Total bilirubin(TBIL)1.0 ULN but direct bilirubin = 120 days after the last dose of study treatment, and have a negative serum pregnancy test <= 7 days before the first administration of the study drug.
Exclusion criteria
Exclusion criteria: Patients who meet the following criteria cannot be included in this study: 1.Received Hormone therapy, radiotherapy, chemotherapy and targeted therapy before enrollment; 2.Concomitant with other malignant diseases or diagnosed with other malignant diseases within 5 years before enrollment; 3.Patients who are known to be allergic to Anlotinib, nab-paclitaxel or carboplatin; 4.Has multiple factors affecting oral medication. Such as inability to swallow, chronic diarrhea and intestinal obstruction; 5.Patients with any severe and/or uncontrolled disease, including: a.Patients whose blood pressure control is not ideal (systolic pressure >= 150 mmHg, diastolic pressure >= 100 mmHg); b.Having grade I or above myocardial ischemia or infarction, arrhythmia (including QTc >= 450ms(male) or QTc >= 470ms(female) and grade >= 2 congestive heart failure (New York Heart Association (NYHA) classification); c.Active or uncontrolled severe infection; d.Antiviral treatment for cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; e.Renal failure requires hemodialysis or peritoneal dialysis; f.A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a History of organ transplantation; g.Poor control of diabetes mellitus (FBG) > 10mmol/L; h.Urine routine indicated urinary protein >= ++, and confirmed 24-hour quantitative urinary protein > 1.0g; i.Patients with epileptic seizures requiring treatment; 6.Patients whose tumors have invaded around important blood vessels according to imaging findings or whose tumors are likely to invade important blood vessels or whose tumors are obviously necrotic and cause fatal massive hemorrhage according to the judgment of the researchers during the follow-up study; 7.Patient has experienced A number of thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months; 8.History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months; 9.Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, gastric and duodenal active ulcers, ulcerative colitis, or unresected tumors have active bleeding, or may be caused as determined by the researchers. Other conditions of gastrointestinal bleeding and perforation; 10.Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage; 11.Patients who have participated in clinical trials of other drugs within 4 weeks; Concomitant diseases that, according to the investigator's judgment, may seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;iDFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactHongyuan Li
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed