Clinical trial · Interventional
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
NCT01199432CI-TRIAL-00018233completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU（intravenous bolus）+epirubicin+cyclophosphamide | Drug | — | UNRESOLVED |
| 5-FU（intravenous infusion）+epirubicin+cyclophosphamide | Drug | — | UNRESOLVED |
| epirubicin+cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group B(CEF)
- interventionNames
- Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide
- type
- EXPERIMENTAL
- label
- Group A(CEFci)
- interventionNames
- Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Group C(EC)
- interventionNames
- Drug: epirubicin+cyclophosphamide
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.