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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: epirubicin+cyclophosphamide; Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide; Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide

• Registration Number: NCT01199432
• Lead Sponsor: Tao OUYANG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2010-10
• Status Verified: 2014-06
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 501

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C(EC)	epirubicin+cyclophosphamide	-
Group A(CEFci)	5-FU（intravenous infusion）+epirubicin+cyclophosphamide	-
Group B(CEF)	5-FU（intravenous bolus）+epirubicin+cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Pathologic complete response （PCR）	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 Outcome Measures

Name	Time	Method
Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC	at the last day of every chemotherapy cycle	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	up to a week after operation

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China