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

NCT01199432 | Completed Phase 4 DMC

• 1 other identifier: BCP06
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Primary Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

Group B(CEF)

EXPERIMENTAL

Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide

Group A(CEFci)

EXPERIMENTAL

Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide

Group C(EC)

ACTIVE COMPARATOR

Drug: epirubicin+cyclophosphamide

Interventions

5-FU（intravenous infusion）+epirubicin+cyclophosphamide DRUG

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

Also known as: CEFci

Group A(CEFci)

5-FU（intravenous bolus）+epirubicin+cyclophosphamide DRUG

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.

Also known as: CEF

Group B(CEF)

epirubicin+cyclophosphamide DRUG

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.

Also known as: EC

Group C(EC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Tao OUYANG: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EC regimen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tao Ouyang, Doctor

  Beijing Cancer Hospital Breast Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Breast Center

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 10, 2015

Record last verified: 2014-06

Locations

CN (1)