Heart FailureCaTOBNCT02440620
Cardiac Toxicity in Medical Treatment of Breast Cancer
An observational study of Heart Failure and Breast Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer. In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Breast Cancer
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HER2 positive breast cancer in adjuvant treatment with trastuzumab.
Who may be able to join
- Diagnosis of HER2 positive breast cancer
- Adjuvant treatment with trastuzumab
Who cannot join
- Left ventricle ejection fraction (LVEF) <50%
- Chronic or persistent atrial fibrillation
- History of moderate or severe valvular heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.
In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.
- Conditions
- Heart Failure, Breast Cancer
- Keywords
- Heart failure related to medical treatment of breast cancer
- Medical subject headings
- Heart Failure, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Global longitudinal strain by two dimentional speckle tracking.
Measured: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).
Measured: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Ann Banke, Odense University Hospital
- Investigators
- Jacob Moeller, MD, DMsc, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440620
- Sponsor's protocol ID
- S-20140090
- Acronym
- CaTOB
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2015
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Toxicity in Medical Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT02440620
- Acronym / sponsor ID
- CaTOB / S-20140090
- Conditions
- Heart Failure, Breast Cancer
- Keywords
- Heart failure related to medical treatment of breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 May 2015 (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.
This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.
In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2 positive breast cancer in adjuvant treatment with trastuzumab.
Key inclusion criteria (2 listed)
- Diagnosis of HER2 positive breast cancer
- Adjuvant treatment with trastuzumab
Key exclusion criteria (3 listed)
- Left ventricle ejection fraction (LVEF) <50%
- Chronic or persistent atrial fibrillation
- History of moderate or severe valvular heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global longitudinal strain by two dimentional speckle tracking.
Time frame: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).
Time frame: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
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 1 May 2019.
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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.
Jacob Moeller, MD, DMsc study director
Odense University Hospital
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 Heart Failure and Breast Cancer, run by Odense University Hospital at 1 site in Denmark.
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 2 inclusion and 3 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 1 May 2019. 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 Denmark. 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?
Global longitudinal strain by two dimentional speckle tracking. (time frame: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.). The study lists 2 primary outcomes in all. 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 1 May 2019.