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Real World Efficiency of Trastuzumab in Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT01894711
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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

Condition or disease Intervention/treatment
Breast Cancer Drug: Trastuzumab

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Study Type : Observational
Actual Enrollment : 2684 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer
Study Start Date : May 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

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 Name: Herceptin




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894711


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ Maastricht
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Vivianne CG Tjan-Heijnen, MD. Maastricht University Medical Centre

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01894711     History of Changes
Other Study ID Numbers: MEC 09-4-075
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents