Breast CancerPhase 2NCT00256360
Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
A Phase 2 study testing dose dense with neulasta in people with Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dose dense with neulasta
- How many people
- 117 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2005to May 2006
- Phase
- Phase 2
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven early breast cancer requiring adjuvant chemotherapy (lymph node positive or other features of high risk according to St-Gallen criteria)
- Margins of resection histologically free of invasive carcinoma and ductal carcinoma in situ.
- Radiotherapy performed according to center's policy and always follows completion of adjuvant chemotherapy
- Performance status 0 to 1 on the ECOG scale (Appendix A)
- The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH
- Age > 18 years and age <70 years (upper age limit based on the lack of safety data for this population).
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- Normal cardiac function (assessment of LVEF by MUGA scan or echocardiography above the lower limit of normal for the institution).
- Adequate organ function (as defined by neutrophils > 1.5 x109/L, Platelets > 100 x 109/L, Hemoglobin > 10 g/dl, total bilirubin > 1 UNL, ASAT (SGOT) and ALAT (SGPT) > 1.5 UNL, alkaline phosphatase > 2.5 UNL, creatinine > 1.5 mg/dl (150 µmol/L)
- Complete staging work-up within 2 months prior to registration. All patients will have bilateral mammography, chest X-ray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. In case of positive bone scan suspicious for metastases, bone X-ray (or bone CT-scan on spinal hot spots) is mandatory to rule out the possibility of metastatic disease. Other tests may be performed as clinically indicated.
- Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during study treatment (chemotherapy, radiotherapy and endocrine therapy). No pregnant or lactating patients are allowed.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Who cannot join
- Metastatic disease (M1) or inoperable residual axillary disease
- Prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy)
- Prior radiation therapy for breast cancer.
- Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria.
- Pregnant or lactating patients
- Other serious illness or medical condition:
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- Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias.
- History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.
- Active uncontrolled infection
- Active peptic ulcer, unstable diabetes mellitus.
- Past or current history of other neoplasm except for curatively treated basal cell skin cancer or in situ carcinoma of the cervix.
- Chronic treatment with steroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone or equivalent)
- Concurrent treatment with hormonal replacement therapy: this treatment should be stopped at least 15 days before study entry.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer. Several phase III and phase II clinical trials showed the benefits of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC. The aim of the study is also to demonstrate that further shortening of treatment interval from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient's safety. The results of this randomized phase II study should serve as a basis for follow-up randomized phase III trial comparing conventional versus densified sequential FEC and docetaxel based regimens.
Read the detailed description
Arm A:
The three cycles of conventional FEC followed by three cycles of docetaxel regimen will be given at the following doses:
Fluorouracil 500 mg/m² by i.v. bolus or infusion, Epirubicin 100 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 500 mg/m² by i.v. bolus or infusion followed by docetaxel 100 mg/m2 i.v. infusion. All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors.
Pegfilgrastim is only allowed in secondary prophylaxis: febrile neutropenia or prolonged grade IV neutropenia. In the event of febrile neutropenia or prolonged grade IV neutropenia, pegfilgrastim or filgrastim is given for treatment, and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy.
The total duration of treatment is 18 weeks.
Arm B:
The three cycles of conventional docetaxel followed by three cycles of FEC regimen will be given at the following doses:
Docetaxel 100 mg/m2 i.v. infusion followed by Fluorouracil 500 mg/m² by i.v. bolus or infusion, Epirubicin 100 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 500 mg/m² by i.v. bolus or infusion. All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors.
Pegfilgrastim is only allowed in secondary prophylaxis: febrile neutropenia or prolonged grade IV neutropenia. In the event of febrile neutropenia or prolonged grade IV neutropenia, pegfilgrastim or filgrastim is given for treatment, and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy.
The total duration of treatment is 18 weeks.
Arm C:
The four cycles of dose-dense FEC followed by four cycles dose-dense docetaxel regimen will be given at the following doses:
Fluorouracil 375 mg/m² by i.v. bolus or infusion, Epirubicin 75 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 375 mg/m² by i.v. bolus or infusion followed by docetaxel 75 mg/m2. FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle and docetaxel will be given on Day 1 of each 14-day cycle.
Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection will be given in on Day 2 of each study cycle.
The total duration of treatment is 14 weeks.
Arm D:
The four cycles of dose-dense docetaxel followed by four cycles dose-dense FEC regimen will be given at the following doses:
Docetaxel 75 mg/m² followed Fluorouracil 375 mg/m² by i.v. bolus or infusion, Epirubicin 75 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 375 mg/m² by i.v. bolus or infusion. Docetaxel will be given on Day 1 of each 14-day cycle and FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle.
Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection will be given on Day 2 of each study cycle.
The total duration of treatment is 14 weeks.
- Conditions
- Breast Cancer
- Being tested
- dose dense with neulasta
- Keywords
- breast cancer, adjuvant, dose dense, docetaxel, pegfilgrastim
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose dense with neulastaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of FEC and docetaxel based sequential regimens given in dose-dense fashion (FEC every 10-11 days and docetaxel every 14 days) with pegfilgrastim in patients with high-risk primary breast cancer.
Secondary outcomes (1)
To assess the safety and tolerability of FEC and docetaxel regimens including (febrile) neutropenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startSep 2005
- Study completionMay 2006
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- St-Augustinus Wilrijk
- Responsible party
- Principal investigator, prof. dr. Hans Wildiers, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Hans Wildiers, MD, PhD, Principal investigator, UZ Gasthuisberg Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256360
- Sponsor's protocol ID
- 2005-001876-11
- Other IDs
- 2005
- Status last verified
- Dec 2014
- First submitted
- 16 Nov 2005
- Last updated
- 9 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00256360
- Acronym / sponsor ID
- 2005-001876-11
- Conditions
- Breast Cancer
- Keywords
- breast cancer, adjuvant, dose dense, docetaxel, pegfilgrastim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- St-Augustinus Wilrijk
- Study start
- Sep 2005
- Study completion
- May 2006
- First posted
- 21 Nov 2005 (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.
The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer. Several phase III and phase II clinical trials showed the benefits of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC. The aim of the study is also to demonstrate that further shortening of treatment interval from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient's safety. The results of this randomized phase II study should serve as a basis for follow-up randomized phase III trial comparing conventional versus densified sequential FEC and docetaxel based regimens.
Detailed description
Arm A:
The three cycles of conventional FEC followed by three cycles of docetaxel regimen will be given at the following doses:
Fluorouracil 500 mg/m² by i.v. bolus or infusion, Epirubicin 100 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 500 mg/m² by i.v. bolus or infusion followed by docetaxel 100 mg/m2 i.v. infusion. All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors.
Pegfilgrastim is only allowed in secondary prophylaxis: febrile neutropenia or prolonged grade IV neutropenia. In the event of febrile neutropenia or prolonged grade IV neutropenia, pegfilgrastim or filgrastim is given for treatment, and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy.
The total duration of treatment is 18 weeks.
Arm B:
The three cycles of conventional docetaxel followed by three cycles of FEC regimen will be given at the following doses:
Docetaxel 100 mg/m2 i.v. infusion followed by Fluorouracil 500 mg/m² by i.v. bolus or infusion, Epirubicin 100 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 500 mg/m² by i.v. bolus or infusion. All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors.
Pegfilgrastim is only allowed in secondary prophylaxis: febrile neutropenia or prolonged grade IV neutropenia. In the event of febrile neutropenia or prolonged grade IV neutropenia, pegfilgrastim or filgrastim is given for treatment, and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy.
The total duration of treatment is 18 weeks.
Arm C:
The four cycles of dose-dense FEC followed by four cycles dose-dense docetaxel regimen will be given at the following doses:
Fluorouracil 375 mg/m² by i.v. bolus or infusion, Epirubicin 75 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 375 mg/m² by i.v. bolus or infusion followed by docetaxel 75 mg/m2. FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle and docetaxel will be given on Day 1 of each 14-day cycle.
Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection will be given in on Day 2 of each study cycle.
The total duration of treatment is 14 weeks.
Arm D:
The four cycles of dose-dense docetaxel followed by four cycles dose-dense FEC regimen will be given at the following doses:
Docetaxel 75 mg/m² followed Fluorouracil 375 mg/m² by i.v. bolus or infusion, Epirubicin 75 mg/m² by 30 minutes i.v. infusion and Cyclophosphamide 375 mg/m² by i.v. bolus or infusion. Docetaxel will be given on Day 1 of each 14-day cycle and FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle.
Pegfilgrastim (Neulasta) fixed dose of 6 mg (0.6 mL of a 10 mg/mL solution) as a single subcutaneous injection will be given on Day 2 of each study cycle.
The total duration of treatment is 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven early breast cancer requiring adjuvant chemotherapy (lymph node positive or other features of high risk according to St-Gallen criteria)
- Margins of resection histologically free of invasive carcinoma and ductal carcinoma in situ.
- Radiotherapy performed according to center's policy and always follows completion of adjuvant chemotherapy
- Performance status 0 to 1 on the ECOG scale (Appendix A)
- The determination of ER and PgR is mandatory (immunohistochemical methods required; ER and/or PgR positivity is defined as > 1% of positive cells). Also determination of Her2neu is mandatory, either by immunohistochemistry or by FISH
Key exclusion criteria (14 listed)
- Metastatic disease (M1) or inoperable residual axillary disease
- Prior systemic anticancer therapy for breast cancer (chemotherapy, hormone therapy of immunotherapy)
- Prior radiation therapy for breast cancer.
- Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria.
- Pregnant or lactating patients
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 |
|---|---|---|
| dose dense with neulasta | Drug | – |
Primary outcome
To assess the feasibility of FEC and docetaxel based sequential regimens given in dose-dense fashion (FEC every 10-11 days and docetaxel every 14 days) with pegfilgrastim in patients with high-risk primary breast cancer.
1 secondary outcome
To assess the safety and tolerability of FEC and docetaxel regimens including (febrile) neutropenia
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 9 Dec 2014.
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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.
Hans Wildiers, MD, PhD principal investigator
UZ Gasthuisberg Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dose dense with neulasta in people with Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 12 inclusion and 14 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 9 Dec 2014. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the feasibility of FEC and docetaxel based sequential regimens given in dose-dense fashion (FEC every 10-11 days and docetaxel every 14 days) with pegfilgrastim in patients with high-risk primary breast cancer.. 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 9 Dec 2014.