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

NCT03888677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1535

Last updated 2019-03-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

5-FU, epirubicin and cyclophosphamide

Tailored dose escalation of epirubicin and cyclophosphamide.

Sponsors & Collaborators

  • Scandinavian Breast Group

    collaborator OTHER

  • Danish Breast Cancer Cooperative Group

    collaborator OTHER

  • Swedish Cancer Society

    collaborator OTHER

  • Swedish Cancer Foundation

    collaborator OTHER

  • Pharmacia Pharmaceutical Company

    collaborator UNKNOWN

  • Swedish Breast Cancer Group

    collaborator OTHER

  • Henrik Lindman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2003-08-31
Completion
2014-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03888677 on ClinicalTrials.gov