Triple negative breast cancer
Conditions
Interventions
Experiment group:The dosing regimen is: nab-paclitaxel + doxorubicin liposome + cyclophosphamide
Sponsors
Affiliated Hospital of Zunyi Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age>=18 years old (subject to the day of signing the informed consent form); 2. Histologically or cytologically confirmed breast cancer; 3. Breast cancer meets the following two criteria: Histologically confirmed invasive breast cancer with a primary tumor lesion > 2 cm in diameter as determined by the research center; Tumor stage: early (T2-3, N0-1, M0), locally advanced (T2-3, N2 or N3, M0; T4a~c,N,M0); 4. Known hormone receptor status (ER and PgR) negative; 5. Confirmed HER2 negative by laboratory test; 6. Left ventricular ejection fraction (LVEF) >=55%; 7. The function of major organs meets the following criteria (no growth factor, blood transfusion therapy within 14 days before randomization): 1) Absolute neutrophil value>=1.5×109/L; 2) Platelet >=90×109/L; 3) hemoglobin >=90g/L; 4) serum creatinine <=1.5 times the upper limit of normal (ULN); 5) serum total bilirubin < = 1.5 times ULN (except for subjects with Gilbert's syndrome); 6) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <=2.5 times ULN; 7) International normalized ratio (INR), activated partial prothrombin time (APTT) or partial thrombin time (PTT) <=1.5 times ULN; 8. Eastern Cooperative Oncology Group (ECOG) physical status score of 0~1; 9. Those who voluntarily sign the informed consent form, understand the nature, purpose and test procedures of this trial and voluntarily comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer and inflammatory breast cancer; 2. Bilateral breast cancer; 3. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 4. Serious heart disease or discomfort, including but not limited to the following diseases/conditions: 1) Currently suffering from untreated or uncontrolled hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg) or unstable angina pectoris; 2) According to the New York Heart Association (NYHA) classification criteria, currently has a history of congestive heart failure of any grade, or severe arrhythmia requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia); 3) History of myocardial infarction within the first 6 months of randomization; 5. Positive for human immunodeficiency virus (HIV) antibodies; Positive for hepatitis C virus (HCV) antibodies and positive for hepatitis C virus RNA test results; Hepatitis B (hepatitis B core antibody [HBcAb] or hepatitis B surface antigen [HBsAg] is positive, and hepatitis B virus DNA test result is positive; 6. Individuals who are known to be allergic to any component or excipient of the investigational drug; 7. It is known that the subject has a history of mental illness and poor compliance; 8. It is known that the subjects have drug abusers; 9. Participants who participated in other clinical trials within the first 4 weeks of randomization and received intervention therapy; 10. Patients who require intravenous antibiotic treatment due to infection within 7 days prior to randomization; 11. Those who have undergone major surgery within the 4 weeks prior to randomization or are expected to undergo major surgery during the trial period; 12. For women who have not yet reached menopause (defined as non treatment induced amenorrhea for >= 12 months) or have not undergone surgical sterilization (such as removal of ovaries and/or uterus): do not agree to use one or more effective contraceptive measures during the treatment period and at least 6 months after the last study treatment; The blood pregnancy test is positive; Pregnant or lactating women; 13. Researchers believe that individuals who are not suitable for inclusion or may not be able to complete this experiment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Proportion of CR and PR subjects from initial assessment to preoperative evaluation;Tumor evaluation based on the Response Evaluation Criteria for Solid Tumors (RECIST) 1.1; | — |
Countries
China
Contacts
Public ContactLi Taolang
Affiliated Hospital of Zunyi Medical University
Outcome results
None listed