Understanding CARdiac Events in Breast Cancer

Breast Cancer Clinical Trial

— UCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921279
• Other study ID #: C.A. 2890
• Status: Recruiting
• Start date: January 14, 2023
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: National University of Ireland, Galway, Ireland
• Contact: Osama Soliman, MBBCh, PhD
• Phone: +35391493781
• Email: osama.soliman[@]nuigalway.ie
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiomyopathies
• Cardiotoxicity
• Cardiovascular Diseases
• Chemotherapeutic Toxicity
• Heart Failure
• Neoplasms
• Oncology

Locations

Country	Name	City	State
Ireland	Galway Clinic	Galway
Ireland	Galway University Hospital	Galway
Ireland	Mayo University Hospital	Mayo
Ireland	Sligo General Hospital	Sligo

Sponsors (3)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Clinical Research Facility Galway, CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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