Breast CancerPhase 4NCT01199432
Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
A Phase 4 study testing 5-FU（intravenous infusion）+epirubicin+cyclophosphamide, 5-FU（intravenous bolus）+epirubicin+cyclophosphamide and epirubicin+cyclophosphamide in people with Breast Cancer, run by Tao OUYANG at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 5-FU（intravenous infusion）+epirubicin+cyclophosphamide, 5-FU（intravenous bolus）+epirubicin+cyclophosphamide and epirubicin+cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- 5-FU（intravenous infusion）+epirubicin+cyclophosphamide, 5-FU（intravenous bolus）+epirubicin+cyclophosphamide, epirubicin+cyclophosphamide
- Keywords
- Primary Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FU（intravenous infusion）+epirubicin+cyclophosphamideDrug
Also called CEFci
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+cyclophosphamideDrug
Also called CEF
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+cyclophosphamideDrug
Also called EC
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.
| Study group | Role | What they receive |
|---|---|---|
| Group B(CEF) | Experimental | Not described Receives: Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide |
| Group A(CEFci) | Experimental | Not described Receives: Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide |
| Group C(EC) | Active comparator | Not described Receives: Drug: epirubicin+cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to four weeks after surgery
Secondary outcomes (2)
Number of Participants with Ⅲ° and Ⅳ° 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.
Measured: at the last day of every chemotherapy cycle
Number of patients undergoing breast conserving surgery
Measured: up to a week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao OUYANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao OUYANG, Peking University
- Investigators
- Tao Ouyang, Doctor, Study chair, Beijing Cancer Hospital Breast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199432
- Sponsor's protocol ID
- BCP06
- Status last verified
- Jun 2014
- First submitted
- 9 Sep 2010
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01199432
- Acronym / sponsor ID
- BCP06
- Conditions
- Breast Cancer
- Keywords
- Primary Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (estimated)
- Lead sponsor
- Tao OUYANGUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B(CEF) | Experimental | Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide |
| Group A(CEFci) | Experimental | Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide |
| Group C(EC) | Active comparator | Drug: epirubicin+cyclophosphamide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FU（intravenous infusion）+epirubicin+cyclophosphamideAlso: CEFci5-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 | Drug | Group A(CEFci) |
| 5-FU（intravenous bolus）+epirubicin+cyclophosphamideAlso: CEF5-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. | Drug | Group B(CEF) |
| epirubicin+cyclophosphamideAlso: ECepirubicin 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. | Drug | Group C(EC) |
Primary outcome
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)
2 secondary outcomes
Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC
Time frame: at the last day of every chemotherapy cycle
Number of patients undergoing breast conserving surgery
Time frame: up to a week after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Ouyang, Doctor study chair
Beijing Cancer Hospital Breast Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5-FU（intravenous infusion）+epirubicin+cyclophosphamide, 5-FU（intravenous bolus）+epirubicin+cyclophosphamide and epirubicin+cyclophosphamide in people with Breast Cancer, run by Tao OUYANG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response （PCR） (time frame: up to four weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.