Triple Negative Breast Cancer
Conditions
Interventions
No grouping:Nab-Paclitaxel /Carboplatin/Tislelizumab
Sponsors
Sun Yat-Set Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, aged >= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) score 0-1; 3. Has previously untreated, locally advanced TNBC: Estrogen receptor immunohistochemistry (IHC) tumor staining = 1.5 x 10^9/L Platelets >= 100 x 10^9/L hemoglobin >= 90 g/L (2)Serum creatinine = 30 g/L. 7.Life expectancy >= 3 months; 8.Cardiac left ventricular ejection fraction (LVEF)>= 50% or >= the lower limit of normal (LLN) was assessed by echocardiography (ECHO) or multigate nuclide angiography (MUGA). 9.Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through >= 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: 1.Any active malignancy 10 mg/day) or other immunosuppressive agents within 14 days of the first dose of study drug. 7.Has a known history of Human Immunodeficiency Virus (HIV). 8.Has known active Hepatitis B or Hepatitis C. 9.Has a history of interstitial lung disease, pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung disease. 10.Serious chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first dose of study drug. Note: patients with viral hepatitis can receive antiviral therapy. 11.Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 11.months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV. 12.Active mental system diseases (schizophrenia, severe depressive disorder, bipolar disorder, etc.). 13.Has a known hypersensitivity to the components of the study treatment. 14.Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study. 15.Pregnant or breastfeeding. 16.Has previous heterologous stem cell transplantation or organ transplantation. 17.Other conditions which, in the opinion of the investigator, make them unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pCR rate of all patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate in PD-L1-positive patients;The pCR rate of all patient and PD-L1-positive patients;Event free survival;Overall survival rate;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactQiang Liu
Sun Yat-Set Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed