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Real World Efficiency of Trastuzumab in Early Breast Cancer

NCT01894711 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2684

Last updated 2013-07-10

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Trastuzumab

Treatment with trastuzumab in HER2 positive patients

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Vivianne CG Tjan-Heijnen, MD. · Maastricht University Medical Centre

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

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 NCT01894711 on ClinicalTrials.gov