Real World Efficiency of Trastuzumab in Early Breast Cancer

NCT01894711 | Completed DMC

• 1 other identifier: MEC 09-4-075
• Study Type: observational
• Target: 2,684
• Locations: 1 country
• Sites: 1

Brief Summary

AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands. RESEARCH QUESTIONS / OBJECTIVES

1. 1.Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
2. 2.Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?
3. 3.Actual trastuzumab administration as opposed to planned trastuzumab administration
4. 4.Selection criteria for chemotherapy and trastuzumab in daily practice
5. 5.Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
6. 6.Disease-free, breast cancer specific, and overall survival in relation to trastuzumab
7. 7.Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
8. 8.Cost-effectiveness of trastuzumab in clinical trials versus in real world

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Cost-effectiveness os trastuzumab in adjuvant breast cancer patients

  volume and cost, within an average of 5-year between diagnosis and last follow up

Study Arms (1)

Patients with HER2 positive tumors

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

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

Treatment with trastuzumab in HER2 positive patients

Also known as: Herceptin

Patients with HER2 positive tumors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals. That is, no distant metastasis at the time of the primary diagnosis

You may qualify if:

• All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.

You may not qualify if:

• Distant metastasis at the time of the primary diagnosis

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ Maastricht, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Vivianne CG Tjan-Heijnen, MD.

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 10, 2013
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

NL (1)