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NCT Number: NCT01199432

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 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.

Other names: 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.

Other names: EC

Primary outcomes

  1. 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

  1. Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC

    Time frame: 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.

  2. Number of patients undergoing breast conserving surgery

    Time frame: up to a week after operation

Sponsors and collaborators

Lead sponsor

Tao OUYANG

Other

Registry information

Official study title

A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2010
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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