Breast CancerPhase 3NCT03888677
Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer
A Phase 3 study testing 5-FU, epirubicin and cyclophosphamide in people with Breast Cancer, run by Henrik Lindman.
Trial summary
This is an open randomized phase III study. The primary objective of this study is to compare FEC adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated according to the patients surface area or with doses adjusted according to leukopenia after course one in order to achieve… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 5-FU, epirubicin and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,535 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Jul 2014
- Phase
- Phase 3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Node positive or 2) High-risk node negative#
- no major cardiovascular morbidity
- female age 18-60
- ECOG/WHO performance status <1
- histologically proven invasive breast cancer
- written or oral witnessed informed consent according to the local Ethics Committee requirements
- start of adjuvant chemotherapy within 8 weeks after surgery
Who cannot join
- distant metastases (M1)
- locally advanced cancer
- nonradically operated (positive resection margins)
- pregnancy or lactation
- leukocyte count < 3.5 x109 /l
- platelets < 100 x109 /l
- other serious medical condition
- previous or concurrent malignancies at other sites, except basal cell carcinoma and carcinoma cervicis uteri in situ
About this study
Official title: SBG 2000-1. Individually Dose-adjusted FEC Compared to Standard FEC as Adjuvant Chemotherapy for Node Positive or High-risk Node Negative Breast Cancer. A Randomized Study by the Scandinavian Breast Group
This is an open randomized phase III study. The primary objective of this study is to compare FEC adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated according to the patients surface area or with doses adjusted according to leukopenia after course one in order to achieve hematological equitoxicity. The main aim of the study is to test whether chemotherapy dosage aimed at hematological equitoxicity will improve the effect of adjuvant chemotherapy.
Read the detailed description
Group A, FECStandard(standard FEC) is given 7 courses of 5-fluorouracil-epirubicin (Farmorubicin)-cyclophosphamide with doses based on the patient's surface area. Leukocyte nadir values at day 10, 12 or 13 and 15 are measured. Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia.
Group B FECTailored(Tailored FEC) receives course one at identical doses to group A. Leukocyte nadir values at day 10,12 or 13 and 15 are measured. Doses of subsequent courses are adjusted to achieve grade 3 leukopenia (leukocyte nadir 1.0 to 2.0) in patients experiencing only grade 0 to 2 leukopenia after course one.
Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia .
Patients achieving only grade 0-2 leukopenia at the first course will be randomized into continued treatment at standard doses (Group A) or to doses tailored to achieve grade 3 leukopenia (Group B). The primary comparisons will be made between these two groups of patients.
Patients with grade 3-4 leukopenia after the first course not be randomized but followed according to the protocol and received treatment as group A, FECStandard.
- Conditions
- Breast Cancer
- Being tested
- 5-FU, epirubicin and cyclophosphamide
- Keywords
- 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, epirubicin and cyclophosphamideDrug
Tailored dose escalation of epirubicin and cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Standard FEC (F600, E60, C600) every 3rd week. Receives: Drug: 5-FU, epirubicin and cyclophosphamide |
| Tailored | Experimental | Tailored FEC (F600, E75-90, C900-1200) every 3rd week. Receives: Drug: 5-FU, epirubicin and cyclophosphamide |
| Registered | Active comparator | Non-randomized arm with patients with grade 3-4 leukopenia after first cycle and treated with standard FEC (F600, E60, C600) every 3rd week. Receives: Drug: 5-FU, epirubicin and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant disease-free survival.
Distant disease-free survival comparing standard and tailored arm.
Measured: 5-10 years
Secondary outcomes (5)
Regio-locally relapsed disease
Regiolocal disease-free survival
Measured: 5-10 years
Overall survival
Overall survival
Measured: 5-10 years
Toxicity of treatment.
Adverse events
Measured: 5-10 years
Leukopenia and correlation to prognosis in distant disease-free survival.
Distant disease-free survival in patients groups based on nadir leukopenia after third cycle.
Measured: 5-10 years.
Effect of dose escalation of leukopenia and correlation to prognosis in distant disease-free survival.
Comparing distant disease-free survival difference between patients randomized to tailored and dose-escalated FEC with the Group of patients with standard FEC but with similar grade of leukopenia.
Measured: 5-10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study startFeb 2001
- Primary completionAug 2003
- Study completionJul 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Lindman
- Sponsor type
- University, hospital or other
- Collaborators
- Scandinavian Breast Group, Danish Breast Cancer Cooperative Group, Swedish Cancer Society, Swedish Cancer Foundation, Pharmacia Pharmaceutical Company, Swedish Breast Cancer Group
- Responsible party
- Sponsor-investigator, Henrik Lindman, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888677
- Sponsor's protocol ID
- SBG 2000-1
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing with EBCTCG (Early Breast Cancer Trialists' Collaborative Group).
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBG 2000-1. Individually Dose-adjusted FEC Compared to Standard FEC as Adjuvant Chemotherapy for Node Positive or High-risk Node Negative Breast Cancer. A Randomized Study by the Scandinavian Breast Group
- ClinicalTrials.gov ID
- NCT03888677
- Acronym / sponsor ID
- SBG 2000-1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,535 participants (actual)
- Lead sponsor
- Henrik LindmanUniversity, hospital or other
- Collaborators
- Scandinavian Breast Group, Danish Breast Cancer Cooperative Group, Swedish Cancer Society, Swedish Cancer Foundation, Pharmacia Pharmaceutical Company, Swedish Breast Cancer Group
- Study start
- Feb 2001 (actual)
- Primary completion
- Aug 2003 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Mar 2019 (actual)
- 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 an open randomized phase III study. The primary objective of this study is to compare FEC adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated according to the patients surface area or with doses adjusted according to leukopenia after course one in order to achieve hematological equitoxicity. The main aim of the study is to test whether chemotherapy dosage aimed at hematological equitoxicity will improve the effect of adjuvant chemotherapy.
Detailed description
Group A, FECStandard(standard FEC) is given 7 courses of 5-fluorouracil-epirubicin (Farmorubicin)-cyclophosphamide with doses based on the patient's surface area. Leukocyte nadir values at day 10, 12 or 13 and 15 are measured. Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia.
Group B FECTailored(Tailored FEC) receives course one at identical doses to group A. Leukocyte nadir values at day 10,12 or 13 and 15 are measured. Doses of subsequent courses are adjusted to achieve grade 3 leukopenia (leukocyte nadir 1.0 to 2.0) in patients experiencing only grade 0 to 2 leukopenia after course one.
Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia .
Patients achieving only grade 0-2 leukopenia at the first course will be randomized into continued treatment at standard doses (Group A) or to doses tailored to achieve grade 3 leukopenia (Group B). The primary comparisons will be made between these two groups of patients.
Patients with grade 3-4 leukopenia after the first course not be randomized but followed according to the protocol and received treatment as group A, FECStandard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: 5-FU, epirubicin and cyclophosphamideStandard FEC (F600, E60, C600) every 3rd week. |
| Tailored | Experimental | Drug: 5-FU, epirubicin and cyclophosphamideTailored FEC (F600, E75-90, C900-1200) every 3rd week. |
| Registered | Active comparator | Drug: 5-FU, epirubicin and cyclophosphamideNon-randomized arm with patients with grade 3-4 leukopenia after first cycle and treated with standard FEC (F600, E60, C600) every 3rd week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Node positive or 2) High-risk node negative#
- no major cardiovascular morbidity
- female age 18-60
- ECOG/WHO performance status <1
- histologically proven invasive breast cancer
Key exclusion criteria (8 listed)
- distant metastases (M1)
- locally advanced cancer
- nonradically operated (positive resection margins)
- pregnancy or lactation
- leukocyte count < 3.5 x109 /l
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, epirubicin and cyclophosphamideTailored dose escalation of epirubicin and cyclophosphamide. | Drug | Registered, Standard, Tailored |
Primary outcome
Distant disease-free survival.
Time frame: 5-10 years
Distant disease-free survival comparing standard and tailored arm.
5 secondary outcomes
Regio-locally relapsed disease
Time frame: 5-10 years
Overall survival
Time frame: 5-10 years
Toxicity of treatment.
Time frame: 5-10 years
Leukopenia and correlation to prognosis in distant disease-free survival.
Time frame: 5-10 years.
Effect of dose escalation of leukopenia and correlation to prognosis in distant disease-free survival.
Time frame: 5-10 years.
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 28 Mar 2019.
- Individual participant dataSharing planned: Yes. Sharing with EBCTCG (Early Breast Cancer Trialists' Collaborative Group).
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-FU, epirubicin and cyclophosphamide in people with Breast Cancer, run by Henrik Lindman.
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 7 inclusion and 8 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Distant disease-free survival. (time frame: 5-10 years). 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 28 Mar 2019.