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AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.
RESEARCH QUESTIONS / OBJECTIVES
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with HER2 positive tumors | Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Treatment with trastuzumab in HER2 positive patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor | Disease free survival | events, within an average of 5-year between diagnosis and last follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients treated with trastuzumab who develop (cardio)toxicity? | cardiotoxicity | temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness os trastuzumab in adjuvant breast cancer patients | volume and cost, within an average of 5-year between diagnosis and last follow up |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Vivianne CG Tjan-Heijnen, MD. | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | Limburg | 6202 AZ Maastricht | Netherlands |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |