Understanding CARdiac Events in Breast Cancer (UCARE)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Breast Cancer; Cardiomyopathies; Cardiotoxicity; Chemotherapeutic Toxicity; Oncology

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Osama Soliman, MBBCh, PhD; Phone Number: +35391493781; Email: osama.soliman@nuigalway.ie
• Study Contact Backup: Name: Aoife Lowery, MBBCh, PhD; Email: aoife.lowery@nuigalway.ie

Study Locations

• Ireland
  • Galway, Ireland
    • Recruiting
    • Galway Clinic
  • Galway, Ireland, H91 T861
    • Recruiting
    • Galway University Hospital
    • Contact: Osama Soliman, MBBCH, PHD; Phone Number: +35391493781; Email: osama.soliman@universityofgalway.ie
    • Contact: Aoife Lowery, MBBS, PhD
    • Principal Investigator: Aoife Lowery, MB BCh, PhD
    • Sub-Investigator: Veronica McInerney, MD,PhD
    • Principal Investigator: William Wijns, MD, PhD
    • Principal Investigator: Michael Kerin, MD, PhD
    • Principal Investigator: Maccon Keane, MD,PhD
    • Principal Investigator: Osama Soliman, MB BCh,PhD
    • Principal Investigator: Silvie Blazkova, MB BCh
  • Mayo, Ireland
    • Recruiting
    • Mayo University Hospital
  • Sligo, Ireland
    • Recruiting
    • Sligo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult female patients diagnosed with stage I-III breast cancer receiving chemotherapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Clinical Research Facility Galway; CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
• Investigators: Principal Investigator: Osama Soliman, MBBCh, PhD, NUIG; Principal Investigator: Aoife Lowery, MBBCh, PhD, NUIG; Principal Investigator: Michael Kerin, MD, PhD, NUIG; Principal Investigator: William Wijns, MD, PhD, NUIG

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cardio oncology
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Skin Diseases; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Neoplasms; Cardiovascular Diseases; Breast Neoplasms; Cardiomyopathies; Cardiotoxicity
• Other Study ID Numbers: C.A. 2890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes