Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Neoadjuvant Therapy; Breast Neoplasms

Treatments: Drug: 5-FU; Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01849380

BEST T-01

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Epirubicin-cyclophosphamide-S-1( ECS)

Experimental group

Description:

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.

Treatment:

Drug: S-1

Epirubicin-cyclophosphamide-5-FU (ECF)

Active Comparator group

Description:

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.

Treatment:

Drug: 5-FU