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Completed

NCT Number: NCT01894711

Real World Efficiency of 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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

Treatment with trastuzumab in HER2 positive patients

Other names: Herceptin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 10, 2013
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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