Breast cancer
Conditions
Interventions
Experimental group:Paclitaxel (Albumin Bound)combined with cisplatin
control group:Epirubicin combined with cyclophosphamide sequential docetaxel
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients with invasive breast cancer were >= 18 years old and 2 cm determined by standard evaluation method in the research center; tumor stage: early (T2-3, n0-1, M0) or locally advanced (T2-3, N2 or N3, M0); 4. The function level of main organs was good (blood routine test, biochemical test; function of heart,liver,lung and kidney) 5. The results of pregnancy test of women of childbearing age were negative, and they were willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug; 6. The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension who could not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 2. Patients with severe cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, arrhythmia with poor control (including QTc interval >= 450 ms in male and >= 470 MS in female); with grade III to IV cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) less than 50% according to NYHA standard; 3. Patients with positive proteinuria (urinary protein test 2 + or above, or 24-hour urinary protein quantitative > 1.0g), but patients with weak proteinuria (±) should be carefully enrolled; 4. Patients with abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN) and bleeding tendency; 5. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 6. Patients have been known to have allergic history to the drug components of this regimen; have a history of immune deficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 7. Patients have a serious concomitant disease or other comorbidities that interfere with the planned treatment, or any other situation in which the investigator believes that the patient is not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast conserving rate;event free survival;overall survival; | — |
Countries
China
Contacts
Public ContactZhengkui Sun
Jiangxi Cancer Hospital
Outcome results
None listed