Breast Cancer
Conditions
Interventions
1:Paclitaxel plus Epirubicin
2:Paclitaxel plus Epirubicin
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed and documented adenocarcinoma of the breast with locally advanced disease not amenable to curative resection; 2. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.; 3. No Previous systemic non-hormonal anticancer therapy for the metastatic or locally recurrent disease; 4. Life expectancy of at least 12 weeks; 5. KPS >70; 6. adequate organ function, evidenced by the following laboratory results: (1) Absolute neutrophil count >1,500 cells/mm3; (2) Platelet count =100,000 cells/mm3; (3) Hemoglobin =100g/L; (4) Total bilirubin =2 UNL; (5) Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) =2.5×ULN ( =5×ULN in patients with liver metastases); (6) blood glucose=200mg/dl; (7) Serum creatinine =140 umol/l; 7. Patients with well compliance on protocol, ability on understanding study procedure; Signed written informed consent approved by the relevant Independent Ethics Committee (IEC).
Exclusion criteria
Exclusion criteria: 1. pregnancy and lactation women; 2. Previous systemic non-hormonal anticancer therapy for breast cancer; 3. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma; 4. mental disorder or other condition which affect patient compliance on protocol; 5. Uncontrolled disease or clinically significant; 1) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina,Uncontrolled hypertension,congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication; 2) clinically significant metal disorder, including metal disease,epileptic dementia effect on understanding on ICF; 3) Uncontrolled acute infection; 4) unstable Peptic Ulcer, diabetes mellitus or other contraindication on adrenocortical steroid. 6. Concurrent participation in any interventional clinical trial;or History of receiving any investigational treatment within 30 days prior to enrolled into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficac; | — |
Countries
China
Contacts
Public ContactJiayu Wang
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed