Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Lindman
• Collaborators: Danish Breast Cancer Cooperative Group; Danish Breast Cancer Group; Pharmacia Pharmaceutical Company; Scandinavian Breast Cancer Group; Scandinavian Breast Group; Swedish Breast Cancer Association; Swedish Breast Cancer Group; Swedish Cancer Foundation; Swedish Cancer Society; Uppsala University Oncology Department Trust
• Treatments: Cyclophosphamide; Epirubicin

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