Real World Efficiency of Trastuzumab in Early Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT01894711
• Lead Sponsor: Maastricht University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-11
• Study Completion: 2013-05
• Status Verified: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2684

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with HER2 positive tumors	Trastuzumab	Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands