Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: Cyclophosphamide; Epirubicin

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