Triple negative breast cancer
Conditions
Interventions
1:PLD combined with docetaxel
2:epirubicin combined with docetaxel
Sponsors
Southwest Hospital, Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 70 years old, female; 2) ER negative, PR negative, HER-2 negative by immunohistochemistry (IHC); 3) tumor >=2 cm; 4) There must be at least one measurable lesion (according to RECIST v1.1); 5) ECOG PS =55%; 7) Cardiac function: brain natriuretic peptide (BNP) (or N-terminal pro-brain natriuretic peptide (NT-proBNP)) and cardiac troponin were within the normal range; 8) Liver and kidney function: AST and ALT =3.0x10^9/L, neutrophil>=1.5x10^9/L, platelet>=100x10^9/L, hemoglobin >=90 g/L; 10) The patient has good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1) Stage IV (metastatic) breast cancer; 2) Patient who has a history of reactions to chemotherapeutic drugs or any other component; 3) According to the judgement of the investigators, other anti-tumor treatments (except ovarian function inhibitors) are needed during neoadjuvant therapy; 4) Patients with severe cardiac disease or discomfort who are not expected to tolerate chemotherapy, including but not limited to: a. fatal arrhythmia or higher-grade atrioventricular block (second-degree type 2 [Mobitz2] atrioventricular block or third-degree atrioventricular block); b. unstable angina; c. clinically significant valvular disease; d. electrocardiogram showing transmural myocardial infarction; E. uncontrolled hypertension; 5) uncontrolled diabetes; 6) Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study, including but not limited to active hepatitis virus infection, positive human immunodeficiency virus (HIV) antibody, pulmonary infection, etc. 7) Subjects with concomitant or previous malignancies within the last 5 years ( Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix); 8) Participants who received any other investigational treatment within 4 weeks before the start of the study; 9) Pregnancy, breast-feeding or child-bearing women who refuse contraception during the trial; 10) The investigator judged patients who were not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast conservation rate;5-year DFS;OS;6-cycle ORR; | — |
Countries
China
Contacts
Public ContactXiaowei Qi
Southwest Hospital, Army Medical University
Outcome results
None listed