Understanding CARdiac Events in Breast Cancer

NCT ID: NCT05921279

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-14
• Study Completion Date: 2026-07-31

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).

Conditions

Breast Cancer; Cardiotoxicity; Cardiomyopathies; Chemotherapeutic Toxicity; Heart Failure; Oncology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HRB Clinical Research Facility Galway

OTHER

Sponsor Role: collaborator

CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland

UNKNOWN

Sponsor Role: collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Professor Osama SOLIMAN

Professor of Cardiovascular Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama Soliman, MBBCh, PhD

Role: PRINCIPAL_INVESTIGATOR

NUIG

Aoife Lowery, MBBCh, PhD

Role: PRINCIPAL_INVESTIGATOR

NUIG

Michael Kerin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NUIG

William Wijns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NUIG

Locations

Galway University Hospital

Galway, , Ireland

Site Status: RECRUITING

Galway Clinic

Galway, , Ireland

Site Status: RECRUITING

Mayo University Hospital

Mayo, , Ireland

Site Status: RECRUITING

Sligo General Hospital

Sligo, , Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Osama Soliman, MBBCh, PhD

Role: CONTACT

osama.soliman@nuigalway.ie

+35391493781

Aoife Lowery, MBBCh, PhD

Role: CONTACT

aoife.lowery@nuigalway.ie

Facility Contacts

Osama Soliman, MBBCH, PHD

Role: primary

osama.soliman@universityofgalway.ie

+35391493781

Aoife Lowery, MBBS, PhD

Role: backup

Other Identifiers

C.A. 2890

Identifier Type: -

Identifier Source: org_study_id