Real World Efficiency of Trastuzumab in Early Breast Cancer

July 9, 2013 updated by: Maastricht University Medical Center

Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer

AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.

RESEARCH QUESTIONS / OBJECTIVES

  1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
  2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?

To address the research questions (objectives), the following outcome measures will be determined:

CLINICAL OUTCOME MEASURES

  1. Actual trastuzumab administration as opposed to planned trastuzumab administration
  2. Selection criteria for chemotherapy and trastuzumab in daily practice
  3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac

  4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab

    ECONOMIC OUTCOME MEASURES

  5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
  6. Cost-effectiveness of trastuzumab in clinical trials versus in real world

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ Maastricht
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.

That is, no distant metastasis at the time of the primary diagnosis

Description

Inclusion Criteria:

  • All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.

Exclusion Criteria:

  • Distant metastasis at the time of the primary diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with HER2 positive tumors
Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab
Drug: Trastuzumab
Treatment with trastuzumab in HER2 positive patients
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
Time Frame: events, within an average of 5-year between diagnosis and last follow up
Disease free survival
events, within an average of 5-year between diagnosis and last follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients treated with trastuzumab who develop (cardio)toxicity?
Time Frame: temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up
cardiotoxicity
temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up

Other Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness os trastuzumab in adjuvant breast cancer patients
Time Frame: volume and cost, within an average of 5-year between diagnosis and last follow up
volume and cost, within an average of 5-year between diagnosis and last follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Vivianne CG Tjan-Heijnen, MD., Maastricht University Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 09-4-075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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