Clinical trial NCT05921279: Understanding CARdiac Events in Breast Cancer
Official title: Understanding CARdiac Events in Breast Cancer - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Cardiotoxicity
Cardiomyopathies
Chemotherapeutic Toxicity
Heart Failure
Oncology
Keywords: Cardio oncology
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: HRB Clinical Research Facility Galway
name: CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
First posted: 2023-06-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult female patients diagnosed with stage I-III breast cancer receiving chemotherapy.

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).

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

Primary outcomes:
measure: The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.
timeFrame: 2 years
Secondary outcomes:
measure: The number of participants with cardiovascular disease (CVD) among patients with breast cancer prior to commencement of systemic chemotherapy.
timeFrame: Baseline
measure: The number of participants with common risk factors for CTRCD among patients with breast cancer prior to commencement of systemic chemotherapy.
timeFrame: Baseline
measure: Incidence of CTRCD in Irish breast cancer patients receiving chemotherapy.
timeFrame: 3M, 6M, 9M, 12M, 24M
measure: The number of participants with successful collection and biobanking specimens among patients with breast cancer undergoing systemic chemotherapy.
timeFrame: Baseline, 3M, 6M, 9M, 12M, 24M
measure: The number of participants with successful collection of guideline-required imaging data among patients with breast cancer undergoing systemic chemotherapy.
timeFrame: Baseline, 3M, 6M, 9M, 12M, 24M
measure: The number of participants with successful collection of guideline-required clinical data among patients with breast cancer undergoing systemic chemotherapy.
timeFrame: Baseline, 3M, 6M, 9M, 12M, 24M
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospital
city: Galway
country: Ireland
facility: Galway Clinic
city: Mayo
country: Ireland
facility: Mayo University Hospital
city: Sligo
country: Ireland
facility: Sligo General Hospital
Study officials:
affiliation: NUIG
name: Osama Soliman, MBBCh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NUIG
name: Aoife Lowery, MBBCh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NUIG
name: Michael Kerin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NUIG
name: William Wijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: