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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199432
• Other study ID #: BCP06
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2010
• Last updated: June 9, 2015
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tao OUYANG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants with ?° and ?° Adverse Events According to NCI-CTC	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.	at the last day of every chemotherapy cycle	Yes
Secondary	Number of patients undergoing breast conserving surgery		up to a week after operation	No