Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer
Keywords
Abstract
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.
Dates
| Last Verified: | 02/28/2019 |
| First Submitted: | 03/21/2019 |
| Estimated Enrollment Submitted: | 03/21/2019 |
| First Posted: | 03/24/2019 |
| Last Update Submitted: | 03/24/2019 |
| Last Update Posted: | 03/27/2019 |
| Actual Study Start Date: | 01/31/2001 |
| Estimated Primary Completion Date: | 07/31/2003 |
| Estimated Study Completion Date: | 06/30/2014 |
Condition or disease
Intervention/treatment
Drug: 5-FU, epirubicin and cyclophosphamide
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Standard Standard FEC (F600, E60, C600) every 3rd week. | |
| Experimental: Tailored Tailored FEC (F600, E75-90, C900-1200) every 3rd week. | |
| Active Comparator: 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Distant disease-free survival. [5-10 years]
Secondary Outcome Measures
1. Regio-locally relapsed disease [5-10 years]
2. Overall survival [5-10 years]
3. Toxicity of treatment. [5-10 years]
4. Leukopenia and correlation to prognosis in distant disease-free survival. [5-10 years.]
5. Effect of dose escalation of leukopenia and correlation to prognosis in distant disease-free survival. [5-10 years.]
