Clinical trial · Observational
Real World Efficiency of Trastuzumab in Early Breast Cancer
Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients with HER2 positive tumors
- description
- Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab
- interventionNames
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
- timeFrame
- events, within an average of 5-year between diagnosis and last follow up
- description
- Disease free survival
Secondary outcomes (1)
- measure
- Number of patients treated with trastuzumab who develop (cardio)toxicity?
- timeFrame
- temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available