Understanding CARdiac Events in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorNational University of Ireland, Galway, Ireland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged ≥ 18 years
Ability to read and understand English
Breast Cancer Stage I- III planned to receive systemic chemotherapy
Disqualifiers
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 population
Adult female patients diagnosed with stage I-III breast cancer receiving chemotherapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 4 trial groupsGroup A: Anthracycline based chemotehrapy low and moderate risk
Group B: Anthracycline based chemotherapy - high and very high risk
Group C: Herceptin targeted therapy - low and moderate risk
Group D: Herceptin targeted therapy - high and very high risk
Trial outcomes
Primary outcomes
1
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).
Time frame
2 yearsSecondary outcomes
1
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
Time frame
Baseline2
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
Time frame
Baseline3
Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.
To assess the incidence of CTRCD at all post-therapy timepoints./
Time frame
3M, 6M, 9M, 12M, 24M4
The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.
To collect and biobank relavant samples
Time frame
Baseline, 3M, 6M, 9M, 12M, 24MSponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Ireland, Galway, Ireland
Lead sponsor
HRB Clinical Research Facility Galway
Collaborator
CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
Collaborator
Source ClinicalTrials.gov