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Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer

NCT00689156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2015

Last updated 2018-04-05

No results posted yet for this study

Summary

The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Epirubicin, cyclophosphamide and docetaxel

Epirubicin 90 mg/m2 iv day 1 every 3 weeks plus Cyclophosphamide 600 mg/m2 iv day 1 every 3 weeks times 3 followed by Docetaxel 100 mg/m2 iv day 1 every 3 weeks times 3

DRUG

docetaxel, cyclophosphamide

Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six

Sponsors & Collaborators

  • Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Dako

    collaborator INDUSTRY

  • Danish Breast Cancer Cooperative Group

    lead OTHER

Principal Investigators

  • Bent Ejlertsen, M.D. · Rigshospitalet, Denmark

  • Henning T. Mouridsen, M.D. · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Denmark

Study Locations

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Entities

Companies

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 NCT00689156 on ClinicalTrials.gov