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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide; Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide; Drug: epirubicin+cyclophosphamide

• Study Type: Interventional
• Enrollment (Anticipated): 501
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: EC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete response （PCR）	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)	up to four weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC	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.	at the last day of every chemotherapy cycle
Number of patients undergoing breast conserving surgery		up to a week after operation

Collaborators and Investigators

• Sponsor: Tao OUYANG
• Investigators: Study Chair: Tao Ouyang, Doctor, Beijing Cancer Hospital Breast Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Primary Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Fluorouracil; Epirubicin
• Other Study ID Numbers: BCP06