Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Several studies have proved the safety and efficacy of single agent S-1 in metastatic breast cancer. This study is designed to further investigate and compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs. Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with local advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Epirubicin-cyclophosphamide-S-1( ECS)
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.
干预措施: S-1 (Drug)
Epirubicin-cyclophosphamide-5-FU (ECF)
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.
干预措施: 5-FU (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 12 weeks
Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment No microscopic evidence of residual invasive or non-invasive viable tumor cells in all resected specimens of the breast and axilla. Pathological response will be assessed considering all removed breast and lymphatic tissues from all surgeries. The primary endpoint will be summarized as pathological complete remission rate for each treatment group. Ultrasonic examination will be performed every 2 cycles of treatment for efficacy evaluation.
次要结局
- Disease-free Survival(5 years)
- Tolerability and safety(12 weeks)
研究者
Yu-Zhi Gang
Director of Department of Breast Disease
Shandong University