Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

NCT ID: NCT01849380

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

S-1

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

5-FU

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

5-FU

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

Intervention Type: DRUG

Other Intervention Names

SuLi, QILU Pharmaceutical co.ltd

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yu-Zhi Gang

Director of Department of Breast Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Z Yu, Dr; PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Shandong University

Locations

the Second Hospital of Shandong Universtity

Jinan, Shandong, China

Countries

China

Central Contacts

Gang Z Yu, Dr; PhD

Role: CONTACT

yzg@medmail.com.cn

+86 0531-85875048

Facility Contacts

Gang Z Yu, Dr; PhD

Role: primary

yzg@medmail.com.cn

+86 0531-85875048

Other Identifiers

BEST T-01

Identifier Type: -

Identifier Source: org_study_id