Status:
COMPLETED
Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Lead Sponsor:
Tao OUYANG
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelets ≥ 100,000/ mm3
- Hemoglobin ≥ 10 g/dL
- Adequate hepatic and renal function with:
- Serum bilirubin ≤ 1.5×UNL
- Alkaline phosphatase and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT01199432
Start Date
October 1 2010
End Date
December 1 2014
Last Update
June 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142