Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

Phase 4

• Conditions: Breast Neoplasms; Neoadjuvant Therapy
• Interventions: Drug: S-1; Drug: 5-FU

• Registration Number: NCT01849380
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-06
• Last Update Submitted: 2013-05-06
• Study First Posted: 2013-05-08
• Last Update Posted: 2013-05-08
• Study Start: 2013-06
• Primary Completion: 2013-10
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epirubicin-cyclophosphamide-S-1( ECS)	S-1	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.
Epirubicin-cyclophosphamide-5-FU (ECF)	5-FU	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.

Primary Outcome Measures

Name	Time	Method
Pathological complete response	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.

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival	5 years	The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.; Evaluation will be performed every 2 cycles of treatment during therapy, and follow-up will be performed every 3 months after therapy
Tolerability and safety	12 weeks	Reference to NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v 3.0. The endpoint will be summarized as events rate (%) for each treatment group

Trial Locations

Locations (1)

the Second Hospital of Shandong Universtity; 🇨🇳 Jinan, Shandong, China