Triple negative breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 75 years old, female; 2) Primary breast cancer confirmed by histopathology with T1c stage and above; 3) ER negative, PR negative, HER-2 negative confirmed by immunohistochemistry (IHC); 4) At least one measurable objective lesion with a tumor diameter > 1 cm according to the RECIST 1.1 ; 5) ECOG physical fitness score of 0-1; 6) LVEF=55%; 7) Bone marrow function: neutrophils =1.5×10^9/L, platelets=100×10^9/L, hemoglobin=90g/L; 8) Liver and kidney function: serum creatinine = 1.5 times the upper limit of normal; AST and ALT = 2.5 times the upper limit of normal; total bilirubin = 1.5 times the upper limit of normal, or patients with Gilbert's syndrome = 2.5 times the upper limit of normal; 9) The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form; 10) Volunteer to participate in the study, and both treatment methods are accepted, and are willing to accept one of them randomly.
Exclusion criteria
Exclusion criteria: 1) Receive cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; 2) New York Heart Association (NYHA) scores for heart disease patients above grade II (including grade II); 3) Patients with severe systemic infections or other serious illnesses; 4) Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients; 5) Other malignant tumors have occurred in the past 5 years, except for cured cervical cancer in situ and non-melanoma skin cancer; 6) Pregnancy or lactation, and women of childbearing age who refuse to take appropriate contraceptive measures during the trial; 7) The first dose of research drug participated in other experimental studies within 30 days before drug administration; 8) The investigator judged patients who were not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival;overall survival; | — |
Countries
China
Contacts
Southwest Hospital, Army Medical University