Understanding CARdiac Events in Breast Cancer

Recruiting

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

• Registration Number: NCT05921279
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief 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.

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 Timeline

• Study Start: 2023-01-14
• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Primary Completion: 2026-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.	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).

Secondary Outcome Measures

Name	Time	Method
The number of participants with cardiovascular disease (CVD) among patients with breast cancer prior to commencement of systemic chemotherapy.	Baseline	To assess the incidence of CVD at baseline
The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.	Baseline, 3M, 6M, 9M, 12M, 24M	To collect and biobank relavant samples
The number of participants with successful collection of guideline-required imaging data among patients with breast cancer undergoing systemic chemotherapy.	Baseline, 3M, 6M, 9M, 12M, 24M	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.
The number of participants with successful collection of guideline-required clinical data among patients with breast cancer undergoing systemic chemotherapy.	Baseline, 3M, 6M, 9M, 12M, 24M	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.
The number of participants with common risk factors for CTRCD among patients with breast cancer prior to commencement of systemic chemotherapy.	Baseline	Using the HFA-ICOS risk assessment tool
Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.	3M, 6M, 9M, 12M, 24M	To assess the incidence of CTRCD at all post-therapy timepoints./

Trial Locations

Locations (4)

Galway Clinic; 🇮🇪 Galway, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

Mayo University Hospital; 🇮🇪 Mayo, Ireland

Sligo General Hospital; 🇮🇪 Sligo, Ireland