A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 501
- Locations
- 1
- Primary Endpoint
- Pathologic complete response （PCR）
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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:
- •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 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
Arms & Interventions
Group B(CEF)
Intervention: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide (Drug)
Group A(CEFci)
Intervention: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide (Drug)
Group C(EC)
Intervention: epirubicin+cyclophosphamide (Drug)
Outcomes
Primary Outcomes
Pathologic complete response （PCR）
Time Frame: up to four weeks after surgery
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 Outcomes
- Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC(at the last day of every chemotherapy cycle)
- Number of patients undergoing breast conserving surgery(up to a week after operation)
Investigators
Tao OUYANG
Chairman of Breast Center
Peking University