Real World Efficiency of Trastuzumab in Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894711
• Other study ID #: MEC 09-4-075
• Status: Completed
• Phase: N/A
• First received: July 1, 2013
• Last updated: July 9, 2013
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2684
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab
Treatment with trastuzumab in HER2 positive patients

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness os trastuzumab in adjuvant breast cancer patients		volume and cost, within an average of 5-year between diagnosis and last follow up	Yes
Primary	Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor	Disease free survival	events, within an average of 5-year between diagnosis and last follow up	No
Secondary	Number of patients treated with trastuzumab who develop (cardio)toxicity?	cardiotoxicity	temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up	Yes