Real World Efficiency of Trastuzumab in Early Breast Cancer

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Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab

Study type

Observational

Funder types

Other

Identifiers

NCT01894711
MEC 09-4-075

Details and patient eligibility

About

AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands. RESEARCH QUESTIONS / OBJECTIVES Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given? 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 Actual trastuzumab administration as opposed to planned trastuzumab administration Selection criteria for chemotherapy and trastuzumab in daily practice Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac Disease-free, breast cancer specific, and overall survival in relation to trastuzumab ECONOMIC OUTCOME MEASURES Volumes and costs of diagnostic tests and therapies including those for (distant) relapse Cost-effectiveness of trastuzumab in clinical trials versus in real world

Enrollment

2,684 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

2,684 participants in 1 patient group

Patients with HER2 positive tumors
Description:
Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab
Treatment:
Drug: Trastuzumab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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