Understanding CARdiac Events in Breast Cancer (UCARE)

• ClinicalTrials.gov Identifier: NCT05921279
• Recruitment Status: Recruiting
• First Posted: June 27, 2023
• Last Update Posted: July 25, 2023
• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Clinical Research Facility Galway; CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
• Information provided by (Responsible Party): Professor Osama SOLIMAN, National University of Ireland, Galway, Ireland

Study Description

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.

Condition or disease
Breast Cancer; Cardiotoxicity; Cardiomyopathies; Chemotherapeutic Toxicity; Heart Failure; 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 Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
• Actual Study Start Date: January 14, 2023
• Estimated Primary Completion Date: January 2026
• Estimated Study Completion Date: July 2026

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Biospecimen Retention:   Samples With DNA

Bloods for Biobank specimens - Serum, whole blood, paxgene, plasma and serum

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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

Contacts and Locations

Contacts

Contact: Osama Soliman, MBBCh, PhD; +35391493781; osama.soliman@nuigalway.ie

Contact: Aoife Lowery, MBBCh, PhD; aoife.lowery@nuigalway.ie

Locations

Ireland

Galway University Hospital; Recruiting

Galway, Ireland, H91 T861

Contact: Osama Soliman, MBBCH, PHD +35391493781 osama.soliman@universityofgalway.ie

Contact: Aoife Lowery, MBBS, PhD

Principal Investigator: Osama Soliman, MB BCh,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: Silvie Blazkova, MB BCh

Galway Clinic; Recruiting

Galway, Ireland

Mayo University Hospital; Recruiting

Mayo, Ireland

Sligo General Hospital; Recruiting

Sligo, Ireland

Sponsors and Collaborators

National University of Ireland, Galway, Ireland

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

More Information

• Responsible Party: Professor Osama SOLIMAN, Professor of Cardiovascular Research, National University of Ireland, Galway, Ireland
• ClinicalTrials.gov Identifier: NCT05921279
• Other Study ID Numbers: C.A. 2890
• First Posted: June 27, 2023
• Last Update Posted: July 25, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Professor Osama SOLIMAN, National University of Ireland, Galway, Ireland:

Cardio oncology

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms; Cardiomyopathies; Cardiotoxicity; Cardiovascular Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Heart Diseases; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries