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

Tao OUYANG

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01199432

BCP06

Details and patient eligibility

About

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.

Enrollment: 501 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

501 participants in 3 patient groups

Group B(CEF)

Experimental group

Treatment:

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

Group A(CEFci)

Experimental group

Treatment:

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

Group C(EC)

Active Comparator group

Treatment:

Drug: epirubicin+cyclophosphamide