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

This study is currently recruiting participants.
Verified December 2013 by Peking University
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT01199432
First received: September 9, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: 5-FU(intravenous infusion)+epirubicin+cyclophosphamide
Drug: 5-FU(intravenous bolus)+epirubicin+cyclophosphamide
Drug: epirubicin+cyclophosphamide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 501
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B(CEF) 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
Experimental: Group A(CEFci) 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
Active Comparator: Group C(EC) 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199432

Contacts
Contact: Tao Ouyang, Doctor 0086-10-88196695 ouyanghongtao@263.net

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Tao OUYANG
Investigators
Study Chair: Tao Ouyang, Doctor Beijing Cancer Hospital Breast Center
  More Information

No publications provided

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT01199432     History of Changes
Other Study ID Numbers: BCP06
Study First Received: September 9, 2010
Last Updated: December 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Primary Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on April 17, 2014