Breast CancerUCARENCT05921279
Understanding CARdiac Events in Breast Cancer
An observational study of Breast Cancer and Cardiotoxicity, run by National University of Ireland, Galway, Ireland at 4 sites in Ireland.
Trial summary
In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Cardiotoxicity, Cardiomyopathies
- How many people
- 100 participants
- Where
- 4 sitesIreland
- Study dates
- 14 Jan 2023to Jul 2026
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients diagnosed with stage I-III breast cancer receiving chemotherapy.
Who may be able to join
- Women aged ≥ 18 years
- Ability to read and understand English
- Breast Cancer Stage I- III planned to receive systemic chemotherapy
Who cannot join
- Patients not for systemic chemotherapy with curative intent
- Patients who are unable to co-operate with the study protocol
- Patients who are unable to give informed consent
Trial locations and contacts
4 sites in 1 country.
Aoife Lowery, MBBCh, PhD contact
Ireland4 sites, 4 recruiting
- Recruiting
Galway University Hospital
Galway, H91 T861
Osama Soliman, MBBCH, PHD, +35391493781, osama.soliman@universityofgalway.ie
Aoife Lowery, MBBS, PhD
- Recruiting
Galway Clinic
Galway
- Recruiting
Mayo University Hospital
Mayo
- Recruiting
Sligo General Hospital
Sligo
About this study
Official title: Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts.
This research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. The Cardio-oncology research team at GUH plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.
Read the detailed description
Establishment of a Cardio-Oncology assessment and surveillance pathway for breast cancer patients undergoing adjuvant systemic chemotherapy at GUH and the assessment of the feasibility of trialing this approach for risk assessment and early detection of CTRCD in a multicenter, prospective RCT which will inform future development of clinical services for cancer patients nationally and later internationally.
Study Design:
This study is a prospective, single arm, pilot feasibility study.
Study Population:
The study will focus on adult female patients diagnosed with stage I-III breast cancer (BC).
Data Analysis and Statistics:
The PCORE Investigators have established collaboration with biostatisticians at the INSIGHT SFI centre for data analytics within University of Galway for analysis of the multi-component dataset from UCARE. Questionnaire data to assess health related QoL (quality of life) and physical activity will be collected at baseline and at 6-monthly intervals at 3, 6 and 12 months throughout the study period. Clinically important differences in physical activity levels or HR-QoL scores will be recorded as per the tool specific scoring systems. Multivariate analysis will be performed for association between HRQoL measures and predictors in patients undergoing breast cancer treatment. Baseline to 6, 12, 18 and 24 month changes in HRQoL over time will be described in subgroups defined by their treatment characteristics and tumor and host response to therapy (both oncologic and cardio-toxic).
- Conditions
- Breast Cancer, Cardiotoxicity, Cardiomyopathies, Chemotherapeutic Toxicity, Heart Failure, Oncology
- Keywords
- Cardio oncology
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity, Cardiomyopathies, Heart Failure, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anthracycline based chemotehrapy low and moderate risk | Patients recieving anthracycline based chemotherapy who fall into the low and moderate risk category following HFA - ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology guidelines whilst receiving chemotherapy. | |
| Anthracycline based chemotherapy - high and very high risk | Patients who recieving anthracycline who fall into the high and very high risk category following HFA - ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology guidelines whilst receiving chemotherapy. | |
| Herceptin targeted therapy - low and moderate risk | Patients who are recieving herceptin that fall into the low and moderate risk category following HFA-ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology Guidelines. | |
| Herceptin targeted therapy - high and very high risk | Patients who are recieving herceptin that fall into the high and very high risk category following HFA-ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology Guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.
To calculate the percentage of patients who successfully completed all guideline required investigations for baseline assessments, during and post chemotherapy surveillance i.e. Echocardiography, ECG, and Cardiac biomarkers (troponin and BNP).
Measured: 2 years
Secondary outcomes (6)
The number of participants with cardiovascular disease (CVD) among patients with breast cancer prior to commencement of systemic chemotherapy.
To assess the incidence of CVD at baseline
Measured: Baseline
The number of participants with common risk factors for CTRCD among patients with breast cancer prior to commencement of systemic chemotherapy.
Using the HFA-ICOS risk assessment tool
Measured: Baseline
Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.
To assess the incidence of CTRCD at all post-therapy timepoints./
Measured: 3M, 6M, 9M, 12M, 24M
The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.
To collect and biobank relavant samples
Measured: Baseline, 3M, 6M, 9M, 12M, 24M
The number of participants with successful collection of guideline-required imaging data among patients with breast cancer undergoing systemic chemotherapy.
Feasibility of collection of guideline-required imaging data, defined as the number of participants with successful collection of guidelines-required clinical data among patients with breast cancer undergoing systemic chemotherapy.
Measured: Baseline, 3M, 6M, 9M, 12M, 24M
The number of participants with successful collection of guideline-required clinical data among patients with breast cancer undergoing systemic chemotherapy.
Feasibility of collection of guideline-required clinical data, defined as the number of participants with successful collection of guidelines-required clinical data among patients with breast cancer undergoing systemic chemotherapy.
Measured: Baseline, 3M, 6M, 9M, 12M, 24M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start14 Jan 2023
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- HRB Clinical Research Facility Galway, CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
- Responsible party
- Principal investigator, Professor Osama SOLIMAN, National University of Ireland, Galway, Ireland
- Investigators
- Osama Soliman, MBBCh, PhD, Principal investigator, NUIGAoife Lowery, MBBCh, PhD, Principal investigator, NUIGMichael Kerin, MD, PhD, Principal investigator, NUIGWilliam Wijns, MD, PhD, Principal investigator, NUIG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921279
- Sponsor's protocol ID
- C.A. 2890
- Acronym
- UCARE
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05921279
- Acronym / sponsor ID
- UCARE / C.A. 2890
- Conditions
- Breast Cancer, Cardiotoxicity, Cardiomyopathies, Chemotherapeutic Toxicity, Heart Failure, Oncology
- Keywords
- Cardio oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- HRB Clinical Research Facility Galway, CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- 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.
In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts.
This research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. The Cardio-oncology research team at GUH plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.
Detailed description
Establishment of a Cardio-Oncology assessment and surveillance pathway for breast cancer patients undergoing adjuvant systemic chemotherapy at GUH and the assessment of the feasibility of trialing this approach for risk assessment and early detection of CTRCD in a multicenter, prospective RCT which will inform future development of clinical services for cancer patients nationally and later internationally.
Study Design:
This study is a prospective, single arm, pilot feasibility study.
Study Population:
The study will focus on adult female patients diagnosed with stage I-III breast cancer (BC).
Data Analysis and Statistics:
The PCORE Investigators have established collaboration with biostatisticians at the INSIGHT SFI centre for data analytics within University of Galway for analysis of the multi-component dataset from UCARE. Questionnaire data to assess health related QoL (quality of life) and physical activity will be collected at baseline and at 6-monthly intervals at 3, 6 and 12 months throughout the study period. Clinically important differences in physical activity levels or HR-QoL scores will be recorded as per the tool specific scoring systems. Multivariate analysis will be performed for association between HRQoL measures and predictors in patients undergoing breast cancer treatment. Baseline to 6, 12, 18 and 24 month changes in HRQoL over time will be described in subgroups defined by their treatment characteristics and tumor and host response to therapy (both oncologic and cardio-toxic).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anthracycline based chemotehrapy low and moderate risk | – | –Patients recieving anthracycline based chemotherapy who fall into the low and moderate risk category following HFA - ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology guidelines whilst receiving chemotherapy. |
| Anthracycline based chemotherapy - high and very high risk | – | –Patients who recieving anthracycline who fall into the high and very high risk category following HFA - ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology guidelines whilst receiving chemotherapy. |
| Herceptin targeted therapy - low and moderate risk | – | –Patients who are recieving herceptin that fall into the low and moderate risk category following HFA-ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology Guidelines. |
| Herceptin targeted therapy - high and very high risk | – | –Patients who are recieving herceptin that fall into the high and very high risk category following HFA-ICOS cardiac risk assessment as per the European Society of Cardiology Guidelines. These patients are monitored taking biobank bloods, bloods, ecg and cardiac echo as per the European Society of Cardiology Guidelines. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients diagnosed with stage I-III breast cancer receiving chemotherapy.
Key inclusion criteria (3 listed)
- Women aged ≥ 18 years
- Ability to read and understand English
- Breast Cancer Stage I- III planned to receive systemic chemotherapy
Key exclusion criteria (3 listed)
- Patients not for systemic chemotherapy with curative intent
- Patients who are unable to co-operate with the study protocol
- Patients who are unable to give informed consent
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
The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.
Time frame: 2 years
To calculate the percentage of patients who successfully completed all guideline required investigations for baseline assessments, during and post chemotherapy surveillance i.e. Echocardiography, ECG, and Cardiac biomarkers (troponin and BNP).
6 secondary outcomes
The number of participants with cardiovascular disease (CVD) among patients with breast cancer prior to commencement of systemic chemotherapy.
Time frame: Baseline
The number of participants with common risk factors for CTRCD among patients with breast cancer prior to commencement of systemic chemotherapy.
Time frame: Baseline
Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.
Time frame: 3M, 6M, 9M, 12M, 24M
The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.
Time frame: Baseline, 3M, 6M, 9M, 12M, 24M
The number of participants with successful collection of guideline-required imaging data among patients with breast cancer undergoing systemic chemotherapy.
Time frame: Baseline, 3M, 6M, 9M, 12M, 24M
The number of participants with successful collection of guideline-required clinical data among patients with breast cancer undergoing systemic chemotherapy.
Time frame: Baseline, 3M, 6M, 9M, 12M, 24M
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Aoife Lowery, MBBCh, PhD contact
Osama Soliman, MBBCh, PhD principal investigator
NUIG
Aoife Lowery, MBBCh, PhD principal investigator
NUIG
Michael Kerin, MD, PhD principal investigator
NUIG
4 sites 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 and Cardiotoxicity, run by National University of Ireland, Galway, Ireland at 4 sites in Ireland.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Soliman, MBBCh, PhD (+35391493781, osama.soliman@nuigalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance. (time frame: 2 years). 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 25 Jul 2023.