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NCT Number: NCT05921279

Understanding CARdiac Events in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiomyopathies Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Chemotherapeutic Toxicity Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Neoplasms Neoplasms by Site Oncology Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Galway Clinic, Galway, Ireland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.

    Time frame: 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 outcomes

  1. The number of participants with cardiovascular disease (CVD) among patients with breast cancer prior to commencement of systemic chemotherapy.

    Time frame: Baseline

    To assess the incidence of CVD at baseline

  2. The number of participants with common risk factors for CTRCD among patients with breast cancer prior to commencement of systemic chemotherapy.

    Time frame: Baseline

    Using the HFA-ICOS risk assessment tool

  3. Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.

    Time frame: 3M, 6M, 9M, 12M, 24M

    To assess the incidence of CTRCD at all post-therapy timepoints./

  4. The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.

    Time frame: Baseline, 3M, 6M, 9M, 12M, 24M

    To collect and biobank relavant samples

  5. The number of participants with successful collection of guideline-required imaging data among patients with breast cancer undergoing systemic chemotherapy.

    Time frame: 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.

  6. The number of participants with successful collection of guideline-required clinical data among patients with breast cancer undergoing systemic chemotherapy.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aoife Lowery, MBBCh, PhD

CONTACT

[email protected]

Osama Soliman, MBBCh, PhD

CONTACT

[email protected]

+35391493781

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Collaborators

  • CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
  • HRB Clinical Research Facility Galway

Registry information

Official study title

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

Acronym: UCARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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