Clinical trial NCT01199432: Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Official title: A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Primary Breast Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 501
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pathologic complete response （PCR）
timeFrame: up to four weeks after surgery
Secondary outcomes:
measure: Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC
timeFrame: at the last day of every chemotherapy cycle
measure: Number of patients undergoing breast conserving surgery
timeFrame: up to a week after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Beijing Cancer Hospital Breast Center
name: Tao Ouyang, Doctor
role: STUDY_CHAIR
References: