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Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer

NCT00045032 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5099

Last updated 2017-04-27

Study results available
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Summary

The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Conditions

Interventions

DRUG

Herceptin

Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.

DRUG

Herceptin

Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.

Sponsors & Collaborators

  • Breast International Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • ETOP IBCSG Partners Foundation

    collaborator NETWORK

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Martine J. Piccart-Gebhart, MD, PhD · Jules Bordet Institute

  • Robert E. Coleman, MD, FRCP · Cancer Research Centre at Weston Park Hospital

  • Karen A. Gelmon, MD · British Columbia Cancer Agency

  • Kathleen I. Pritchard, MD · Toronto Sunnybrook Regional Cancer Centre

  • Olivia Pagani, MD · Ospedale Beata Vergine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2005-03-31
Completion
2015-06-30

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Denmark
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • 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 NCT00045032 on ClinicalTrials.gov