Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

NCT01849380 | Unknown Phase 4 DMC

• 1 other identifier: BEST T-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Neoadjuvant Therapy

Keywords

Local Advanced Breast Neoplasms; Neoadjuvant Chemotherapy; S-1

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  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.

  12 weeks

Secondary Outcomes (2)

• Disease-free Survival

  5 years

• Tolerability and safety

  12 weeks

Study Arms (2)

Epirubicin-cyclophosphamide-S-1( ECS)

EXPERIMENTAL

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.

Drug: S-1

Epirubicin-cyclophosphamide-5-FU (ECF)

ACTIVE COMPARATOR

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.

Drug: 5-FU

Interventions

S-1 DRUG

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

Also known as: SuLi, QILU Pharmaceutical co.ltd

Epirubicin-cyclophosphamide-S-1( ECS)

5-FU DRUG

5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),

Epirubicin-cyclophosphamide-5-FU (ECF)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

the Second Hospital of Shandong Universtity

Jinan, Shandong, 250033, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

S 1 (combination); Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gang Z Yu, Dr; PhD

  The Second Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Z Yu, Dr; PhD

CONTACT

+86 0531-85875048; yzg@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Breast Disease

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2018
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

CN (1)