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Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

Primary Purpose

Breast Neoplasms, Neoadjuvant Therapy

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
S-1
5-FU
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Local Advanced Breast Neoplasms, Neoadjuvant Chemotherapy, S-1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • the Second Hospital of Shandong Universtity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epirubicin-cyclophosphamide-S-1( ECS)

Epirubicin-cyclophosphamide-5-FU (ECF)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disease-free Survival
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
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

Full Information

First Posted
May 6, 2013
Last Updated
May 6, 2013
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT01849380
Brief Title
Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer
Official Title
Neoadjuvant Epirubicin-cyclophosphamide-S-1 (ECS) Versus Epirubicin-cyclophosphamide-5-FU (ECF) in Local Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoadjuvant Therapy
Keywords
Local Advanced Breast Neoplasms, Neoadjuvant Chemotherapy, S-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epirubicin-cyclophosphamide-S-1( ECS)
Arm Type
Experimental
Arm 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.
Arm Title
Epirubicin-cyclophosphamide-5-FU (ECF)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
SuLi, QILU Pharmaceutical co.ltd
Intervention 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
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),
Primary Outcome Measure Information:
Title
Pathological complete response
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Disease-free Survival
Description
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
Time Frame
5 years
Title
Tolerability and safety
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Z Yu, Dr; PhD
Phone
+86 0531-85875048
Email
yzg@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Z Yu, Dr; PhD
Organizational Affiliation
The Second Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Hospital of Shandong Universtity
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Z Yu, Dr; PhD
Phone
+86 0531-85875048
Email
yzg@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Gang Z Yu, Dr; PhD

12. IPD Sharing Statement

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Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

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