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Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer

NCT01548677 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1317

Last updated 2019-03-13

No results posted yet for this study

Summary

This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.

Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.

Conditions

  • Breast Cancer
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Circulating Tumor Cells

Interventions

DRUG

trastuzumab

8 mg/kg of loading dose IV over 90 minutes for the first cycle, followed by 6 mg/kg IV over 60 minutes every 3 weeks for the 5 subsequent cycles.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Janssen Diagnostics, LLC

    collaborator INDUSTRY

  • SUCCESS

    collaborator UNKNOWN

  • UNICANCER

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Michail Ignatiadis, MD · Institut Jules Bordet, Brussels, Belgium

  • Martine Piccart, MD · Institut Jules Bordet, Brussels, Belgium

  • Christos Sotiriou, MD · Institut Jules Bordet, Brussels, Belgium

  • Jean-Yves Pierga, MD · Institut Curie, Paris, France

  • Brigitte Rack, MD · Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt, Munich, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Belgium
  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01548677 on ClinicalTrials.gov