Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer
NCT ID: NCT03888677
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1535 participants
INTERVENTIONAL
2001-02-28
2014-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard
Standard FEC (F600, E60, C600) every 3rd week.
5-FU, epirubicin and cyclophosphamide
Tailored dose escalation of epirubicin and cyclophosphamide.
Tailored
Tailored FEC (F600, E75-90, C900-1200) every 3rd week.
5-FU, epirubicin and cyclophosphamide
Tailored dose escalation of epirubicin and cyclophosphamide.
Registered
Non-randomized arm with patients with grade 3-4 leukopenia after first cycle and treated with standard FEC (F600, E60, C600) every 3rd week.
5-FU, epirubicin and cyclophosphamide
Tailored dose escalation of epirubicin and cyclophosphamide.
Interventions
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5-FU, epirubicin and cyclophosphamide
Tailored dose escalation of epirubicin and cyclophosphamide.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Scandinavian Breast Group
OTHER
Danish Breast Cancer Cooperative Group
OTHER
Swedish Cancer Society
OTHER
Swedish Cancer Foundation
OTHER
Pharmacia Pharmaceutical Company
UNKNOWN
Swedish Breast Cancer Group
OTHER
Henrik Lindman
OTHER
Responsible Party
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Henrik Lindman
Senior Consultant, Ass. Professor
Other Identifiers
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SBG 2000-1
Identifier Type: -
Identifier Source: org_study_id
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