A Phase 3 interventional study of 5-FU, epirubicin and cyclophosphamide in Breast Cancer, sponsored by Henrik Lindman. Completed. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Henrik Lindman · Phase 3, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 1,535 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Henrik Lindman is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Standard FEC (F600, E60, C600) every 3rd week.
Drug: 5-FU, epirubicin and cyclophosphamide
Tailored FEC (F600, E75-90, C900-1200) every 3rd week.
Drug: 5-FU, epirubicin and cyclophosphamide
Non-randomized arm with patients with grade 3-4 leukopenia after first cycle and treated with standard FEC (F600, E60, C600) every 3rd week.
Drug: 5-FU, epirubicin and cyclophosphamide
Drug pages: Fluorouracil · Epirubicin · Cyclophosphamide
Tailored dose escalation of epirubicin and cyclophosphamide.
Distant disease-free survival.
Distant disease-free survival comparing standard and tailored arm.
Time frame: 5-10 years
Regio-locally relapsed disease
Regiolocal disease-free survival
Time frame: 5-10 years
Overall survival
Overall survival
Time frame: 5-10 years
Toxicity of treatment.
Adverse events
Time frame: 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.
Time frame: 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.
Time frame: 5-10 years.
No study locations are listed for this record.
Plan to share: Yes — Sharing with EBCTCG (Early Breast Cancer Trialists' Collaborative Group).
Supporting information: Clinical study report
Time frame: After 5 years.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluorouracil · Epirubicin · Cyclophosphamide
Henrik Lindman