Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
This study is currently recruiting participants.
Verified February 2013 by Peking University
Sponsor:
Tao OUYANG
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT01199432
First received: September 9, 2010
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide Drug: epirubicin+cyclophosphamide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Peking University:
Primary Outcome Measures:
- Pathologic complete response （PCR） [ Time Frame: up to four weeks after surgery ] [ Designated as safety issue: No ]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:
- Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC [ Time Frame: at the last day of every chemotherapy cycle ] [ Designated as safety issue: Yes ]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.
- Number of patients undergoing breast conserving surgery [ Time Frame: up to a week after operation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 501 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199432
Contacts
| Contact: Tao Ouyang, Doctor | 0086-10-88196695 | ouyanghongtao@263.net |
Locations
| China, Beijing | |
| Beijing Cancer Hospital | Recruiting |
| Beijing, Beijing, China, 100142 | |
Sponsors and Collaborators
Tao OUYANG
Investigators
| Study Chair: | Tao Ouyang, Doctor | Beijing Cancer Hospital Breast Center |
More Information
No publications provided
| Responsible Party: | Tao OUYANG, Chairman of Breast Center, Peking University |
| ClinicalTrials.gov Identifier: | NCT01199432 History of Changes |
| Other Study ID Numbers: | BCP06 |
| Study First Received: | September 9, 2010 |
| Last Updated: | February 14, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by 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 |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 21, 2013