Breast CancerNCT01894711
Real World Efficiency of Trastuzumab in Early Breast Cancer
An observational study of Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 2,684 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.
Who cannot join
- Distant metastasis at the time of the primary diagnosis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ Maastricht
About this study
Official title: Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer
AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.
RESEARCH QUESTIONS / OBJECTIVES
Read more
- Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
- 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
- Actual trastuzumab administration as opposed to planned trastuzumab administration
- Selection criteria for chemotherapy and trastuzumab in daily practice
- Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
- Disease-free, breast cancer specific, and overall survival in relation to trastuzumab ECONOMIC OUTCOME MEASURES
- Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
- Cost-effectiveness of trastuzumab in clinical trials versus in real world
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
Treatment with trastuzumab in HER2 positive patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with HER2 positive tumors | Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
Disease free survival
Measured: 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?
cardiotoxicity
Measured: temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivianne CG Tjan-Heijnen, MD., Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894711
- Sponsor's protocol ID
- MEC 09-4-075
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01894711
- Acronym / sponsor ID
- MEC 09-4-075
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,684 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.
RESEARCH QUESTIONS / OBJECTIVES
- Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
- 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
- Actual trastuzumab administration as opposed to planned trastuzumab administration
- Selection criteria for chemotherapy and trastuzumab in daily practice
- Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
- Disease-free, breast cancer specific, and overall survival in relation to trastuzumab ECONOMIC OUTCOME MEASURES
- Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
- Cost-effectiveness of trastuzumab in clinical trials versus in real world
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HER2 positive tumors | – | Drug: TrastuzumabPatients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.
Key exclusion criteria (1 listed)
- Distant metastasis at the time of the primary diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: HerceptinTreatment with trastuzumab in HER2 positive patients | Drug | Patients with HER2 positive tumors |
Primary outcome
Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor
Time frame: events, within an average of 5-year between diagnosis and last follow up
Disease free survival
1 secondary outcome
Number of patients treated with trastuzumab who develop (cardio)toxicity?
Time frame: temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivianne CG Tjan-Heijnen, MD. principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor (time frame: events, within an average of 5-year between diagnosis and last follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.