Understanding CARdiac Events in Breast Cancer

Study Overview
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Brief Summary
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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
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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).

Official Title
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Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients

Conditions
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Cardiomyopathies, Chemotherapeutic Toxicity, Heart Failure, Breast Cancer, Cardiotoxicity, Oncology

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥ 18 years Ability to read and understand English Breast Cancer Stage I- III planned to receive systemic chemotherapy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anthracycline based chemotehrapy low and moderate risk<br>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<br>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<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline | 
| Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy. | To assess the incidence of CTRCD at all post-therapy timepoints./ | 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 | 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. | 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. | Baseline, 3M, 6M, 9M, 12M, 24M | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardio oncology