NCT03888677

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,535

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
10.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

March 22, 2019

Last Update Submit

March 25, 2019

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Distant disease-free survival.

    Distant disease-free survival comparing standard and tailored arm.

    5-10 years

Secondary Outcomes (5)

  • Regio-locally relapsed disease

    5-10 years

  • Overall survival

    5-10 years

  • Toxicity of treatment.

    5-10 years

  • Leukopenia and correlation to prognosis in distant disease-free survival.

    5-10 years.

  • Effect of dose escalation of leukopenia and correlation to prognosis in distant disease-free survival.

    5-10 years.

Study Arms (3)

Standard

ACTIVE COMPARATOR

Standard FEC (F600, E60, C600) every 3rd week.

Drug: 5-FU, epirubicin and cyclophosphamide

Tailored

EXPERIMENTAL

Tailored FEC (F600, E75-90, C900-1200) every 3rd week.

Drug: 5-FU, epirubicin and cyclophosphamide

Registered

ACTIVE COMPARATOR

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

Interventions

5-FU, epirubicin and cyclophosphamideDRUG

Tailored dose escalation of epirubicin and cyclophosphamide.

RegisteredStandardTailored

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FluorouracilEpirubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant, Ass. Professor

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 25, 2019

Study Start

February 1, 2001

Primary Completion

August 1, 2003

Study Completion

July 1, 2014

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Sharing with EBCTCG (Early Breast Cancer Trialists' Collaborative Group).

Shared Documents
CSR
Time Frame
After 5 years.