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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Peking University
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT01199432
First received: September 9, 2010
Last updated: June 16, 2014
Last verified: June 2014

September 9, 2010
June 16, 2014
October 2010
December 2014   (final data collection date for primary outcome measure)
Pathologic complete response (PCR) [ Time Frame: up to four weeks after surgery ] [ Designated as safety issue: No ]
pathological evaluation by Miller & Payne Grading System. Pathological complete response (pCR) was defined as no histological evidence of invasive tumor cells in the breast. The presence of DCIS alone was considered as pCR (G5). Residual cancer consisting of scattered tumor cells, not directly measurable, was reported as near pCR (G4)
Pathologic complete response (PCR) [ Time Frame: within a month after surgery ] [ Designated as safety issue: No ]
pathological evaluation by Miller & Payne Grading System. Pathological complete response (pCR) was defined as no histological evidence of invasive tumor cells in the breast. The presence of DCIS alone was considered as pCR (G5). Residual cancer consisting of scattered tumor cells, not directly measurable, was reported as near pCR (G4)
Complete list of historical versions of study NCT01199432 on ClinicalTrials.gov Archive Site
  • Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC [ Time Frame: at the last day of every chemotherapy cycle ] [ Designated as safety issue: Yes ]
    All adverse events that occur after the initiation of the treatment will be handled with utmost attention, and carefully documented. Investigator will identify the adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0, the Common Terminology Criteria for Adverse Events.Development of a severe side effect will be an indication for drop-outs.
  • Number of patients undergoing breast conserving surgery [ Time Frame: up to a week after operation ] [ Designated as safety issue: No ]
  • Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC [ Time Frame: at the end of every chemotherapy cycle ] [ Designated as safety issue: Yes ]
    All adverse events that occur after the initiation of the treatment will be handled with utmost attention, and carefully documented. Investigator will identify the adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0, the Common Terminology Criteria for Adverse Events.Development of a severe side effect will be an indication for drop-outs.
  • Number of patients undergoing breast conserving surgery [ Time Frame: within one week after operation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: 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
    Other Name: CEFci
  • 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.
    Other Name: CEF
  • 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.
    Other Name: EC
  • Experimental: Group B(CEF)
    Intervention: Drug: 5-FU(intravenous bolus)+epirubicin+cyclophosphamide
  • Experimental: Group A(CEFci)
    Intervention: Drug: 5-FU(intravenous infusion)+epirubicin+cyclophosphamide
  • Active Comparator: Group C(EC)
    Intervention: Drug: epirubicin+cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
501
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Tao Ouyang, Doctor 0086-10-88196695 ouyanghongtao@263.net
China
 
NCT01199432
BCP06
Yes
Tao OUYANG, Peking University
Tao OUYANG
Not Provided
Study Chair: Tao Ouyang, Doctor Beijing Cancer Hospital Breast Center
Peking University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP