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Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

NCT01049425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3198

Last updated 2019-08-14

No results posted yet for this study

Summary

The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy.

Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.

Conditions

  • Primary Breast Cancer
  • Her2 Non-overexpressing

Interventions

DRUG

Epirubicin

4 cycles, intravenous use, day 1 every three weeks

DRUG

Cyclophosphamide

4 cycles, intravenous infusion, day 1 every three weeks

DRUG

Docetaxel

4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy

DRUG

Cyclophosphamide

6 cycles, intravenous infusion, day 1 every 3 weeks

DRUG

Docetaxel

6 cycles, intravenous infusion, day one every three weeks

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Ulrike A. Nitz, Prof. Dr. med. · Ev. Krankenhaus Bethesda Moenchengladbach

  • Nadia Harbeck, Prof. Dr. med. · University Hospital Cologne

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
2009-02-05
Primary Completion
2017-03-01
Completion
2018-05-15

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01049425 on ClinicalTrials.gov