Real World Efficiency of Trastuzumab in Early Breast Cancer

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Treatments: Trastuzumab

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