Real World Efficiency of Trastuzumab in Early Breast Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01894711

Enrollment

2684

Registered

2013-07-10

Start date

2010-05-31

Completion date

2013-05-31

Last updated

2013-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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

Interventions

DRUGTrastuzumab

Treatment with trastuzumab in HER2 positive patients

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor	events, within an average of 5-year between diagnosis and last follow up	Disease free survival

Secondary

Measure	Time frame	Description
Number of patients treated with trastuzumab who develop (cardio)toxicity?	temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up	cardiotoxicity

Other

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026