Understanding CARdiac Events in Breast Cancer

NCT05921279 | Recruiting

• 1 other identifier: C.A. 2890
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Cardio oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Baseline

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

  Baseline

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

  3M, 6M, 9M, 12M, 24M

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

  Baseline, 3M, 6M, 9M, 12M, 24M

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Women aged ≥ 18 years
• Ability to read and understand English
• Breast Cancer Stage I- III planned to receive systemic chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• HRB Clinical Research Facility Galway: collaborator
• CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland: collaborator

Study Sites (4)

Galway University Hospital

Galway, H91 T861, Ireland

RECRUITING

Galway Clinic

Galway, Ireland

RECRUITING

Mayo University Hospital

Mayo, Ireland

RECRUITING

Sligo General Hospital

Sligo, Ireland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity; Cardiomyopathies; Heart Failure; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Soliman, MBBCh, PhD

CONTACT

+35391493781; osama.soliman@nuigalway.ie

Aoife Lowery, MBBCh, PhD

CONTACT

aoife.lowery@nuigalway.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Research

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: January 14, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

IE (4)