Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
Breast Neoplasms, Neoadjuvant Therapy
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Local Advanced Breast Neoplasms, Neoadjuvant Chemotherapy, S-1
Eligibility Criteria
Inclusion Criteria:
Disease characteristic:
- Histologically confirmed primary breast cancer by core biopsy (Mammotome or bard needle)
- Disease stage appropriate for neoadjuvant chemotherapy (T≥3cm, N0 or T(2-3cm)N1 or any T, N2)
- Her-2(-); Ki67≥14%
- No previous treatment for breast cancer (chemotherapy, endocrinotherapy, radiotherapy)
Patients characteristic:
- Female patients, age 18 to 70 years old
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy of at least 12 weeks
- Willing to be kept follow-up
- Functions below are maintained in major organs:
- Cardiac status:
LVEF: 50% 45% • Haematopoietic status: Leukocyte count: ≥4.0×109/L Neutrophil count: ≥2.0×109/L Platelet count: ≥100×109/L Hemoglobin: ≥80g/L
• Hepatic status: Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN(no liver metastasis) bilirubin:
• Renal status: BUN ≤ 1.5 x times ULN Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥50 mL/min; Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
• Written informed consent (both biopsy and neoadjuvant chemotherapy) will be obtained for patients for entering this study
Exclusion Criteria:
- Previous treatment for breast cancer (neither local nor systemic therapy)
- Known or suspected distant metastasis
- Potentially pregnant, pregnant, or breast-feeding
- Drug allergy
- Concurrent malignancy or history of other malignancy (except Hodgkin lymphoma)
- Currently active severe infection (Hepatitis included)
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures
- Known history of uncontrolled severe heart disease, myocardial infarction within 6 months, congestive heart failure, unstable angina pectoris, clinically significant hydropericardium or unstable arrhythmias
Sites / Locations
- the Second Hospital of Shandong Universtity
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Epirubicin-cyclophosphamide-S-1( ECS)
Epirubicin-cyclophosphamide-5-FU (ECF)
S-1(SuLi,QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration followed by a 14-day rest, combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly.
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively), combined with by epirubicin(80mg/m2, d1 and d8 respectively) and cyclophosphamide(500mg/m2, d1, infusion). The chemotherapy was applicated 4 cycles 4-weekly.