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

• ClinicalTrials.gov Identifier: NCT01199432
• Recruitment Status: Completed
• First Posted: September 13, 2010
• Last Update Posted: June 10, 2015
• Sponsor: Tao OUYANG
• Information provided by (Responsible Party): Tao OUYANG, Peking University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide; Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide; Drug: epirubicin+cyclophosphamide	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 501 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: October 2010
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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 Name: 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 Name: 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 Name: EC

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

China, Beijing

Beijing Cancer Hospital

Beijing, Beijing, China, 100142

Sponsors and Collaborators

Tao OUYANG

Investigators

• Study Chair: Tao Ouyang, Doctor; Beijing Cancer Hospital Breast Center

More Information

• Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
• ClinicalTrials.gov Identifier: NCT01199432
• Other Study ID Numbers: BCP06
• First Posted: September 13, 2010
• Last Update Posted: June 10, 2015
• Last Verified: June 2014

Keywords provided by Tao OUYANG, Peking University:

Primary Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Cyclophosphamide; Fluorouracil; Epirubicin; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antimetabolites; Antimetabolites, Antineoplastic; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors