Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

NCT ID: NCT01199432

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-12-31

Brief Summary

This is a phase IV, prospective, single-center, open-label, randomized, controlled study. Eligible patients are randomly assigned into three groups. The investigators propose to evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women with primary breast cancer.

Conditions

Breast Cancer

Study Design

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

Study Groups

Group B(CEF)

Group Type: EXPERIMENTAL

5-FU（intravenous bolus）+epirubicin+cyclophosphamide

Intervention Type: DRUG

5-FU 500mg/m2 per day on day 1 and day 8（intravenous bolus）; epirubicin 65mg /m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.

Group A(CEFci)

Group Type: EXPERIMENTAL

5-FU（intravenous infusion）+epirubicin+cyclophosphamide

Intervention Type: DRUG

5-FU 200mg/m2 per day from day 1 to day 28 （Continuous intravenous infusion）; epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed

Group C(EC)

Group Type: ACTIVE_COMPARATOR

epirubicin+cyclophosphamide

Intervention Type: DRUG

epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.

Interventions

5-FU（intravenous infusion）+epirubicin+cyclophosphamide

5-FU 200mg/m2 per day from day 1 to day 28 （Continuous intravenous infusion）; epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed

Intervention Type: DRUG

5-FU（intravenous bolus）+epirubicin+cyclophosphamide

5-FU 500mg/m2 per day on day 1 and day 8（intravenous bolus）; epirubicin 65mg /m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.

Intervention Type: DRUG

epirubicin+cyclophosphamide

epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.

Intervention Type: DRUG

Other Intervention Names

CEFci; CEF; EC

Eligibility Criteria

Inclusion Criteria

• Female patients, age ≦ 65 years old
• Histologically or cytologically confirmed primary breast cancer by core biopsy
• Disease stage appropriate for neoadjuvant chemotherapy (T2～T3，N0～2，M0)
• No previous treatment for breast cancer
• No history of other malignancies
• No currently uncontrolled diseased (e.g., ongoing cardiac dysrhythmias, unstable diabetes) or active infection
• No history of other malignancies
• No currently uncontrolled diseased or active infection
• Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
• Adequate cardiovascular function reserve without a myocardial infarction within the past six month
• Adequate hematologic function with:

1. Absolute neutrophil count (ANC) ≥ 1500/mm3

2. Platelets ≥ 100,000/ mm3

3. Hemoglobin ≥ 10 g/dL

• Adequate hepatic and renal function with:

1. Serum bilirubin ≤ 1.5×UNL

2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤ 2.5 x ULN.

3. Serum creatinine ≤ 1.7 mg/dl

• Knowledge of the investigational nature of the study and Ability to give informed consent
• Ability and willingness to comply with study procedures

Exclusion Criteria

• Known or suspected distant metastases
• Concurrent malignancy or history of other malignancy
• Uncontrolled diseases or active infection
• Hepatic or renal dysfunction as detailed above
• Geographical, social, or psychological problems that would compromise study compliance
• Known or suspected hypersensitivity to cyclophosphamide, epirubicin and fluorouracil

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tao OUYANG

OTHER

Sponsor Role: lead

Responsible Party

Tao OUYANG

Chairman of Breast Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tao Ouyang, Doctor

Role: STUDY_CHAIR

Beijing Cancer Hospital Breast Center

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BCP06

Identifier Type: -

Identifier Source: org_study_id