Clinical trial · Interventional
Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU, epirubicin and cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard
- description
- Standard FEC (F600, E60, C600) every 3rd week.
- interventionNames
- Drug: 5-FU, epirubicin and cyclophosphamide
- type
- EXPERIMENTAL
- label
- Tailored
- description
- Tailored FEC (F600, E75-90, C900-1200) every 3rd week.
- interventionNames
- Drug: 5-FU, epirubicin and cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Registered
- description
- 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
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available