Real World Efficiency of Trastuzumab in Early Breast Cancer

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Observational

Funder types: Other

Identifiers

NCT01894711

MEC 09-4-075

Details and patient eligibility

About

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

Enrollment: 2,684 patients

Sex: All

Volunteers: No 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

Trial design

2,684 participants in 1 patient group

Patients with HER2 positive tumors

Description:

Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab

Treatment:

Drug: Trastuzumab