The goal of this observational study is to evaluate cardiac side effects in women with early-stage breast cancer who receive systemic chemotherapy and/or anti-HER2 therapy as part of their standard cancer care.
The main questions it aims to answer are:
Can changes in Global Longitudinal Strain (GLS) on echocardiography detect early cardiac dysfunction before a drop in left ventricular ejection fraction (LVEF) becomes apparent? Are changes in circulating microRNA levels in the blood associated with early cardiac dysfunction during cancer treatment? Does cardiac dysfunction occur more frequently with anthracycline-containing chemotherapy compared to anthracycline-free regimens?
Participants already receiving standard chemotherapy and/or anti-HER2 therapy as part of their routine cancer care will undergo echocardiography (LVEF and GLS), provide blood samples for microRNA analysis, and complete quality of life questionnaires at four time points: before treatment (baseline), and at 3, 6, and 12 months after starting treatment.
Histologically confirmed diagnosis of breast cancer
Stage I, II, or III disease
Planned neoadjuvant or adjuvant chemotherapy and/or HER2-targeted systemic therapy
Baseline transthoracic echocardiographic left ventricular ejection fraction (LVEF) ≥ 50%
Metastatic (Stage IV) breast cancer
Pre-existing heart failure or clinically significant cardiac disease
Prior exposure to chemotherapy or other cardiotoxic systemic therapy
Concurrent active malignancy other than breast cancer
Adult women with histologically confirmed Stage I-III breast cancer for whom neoadjuvant or adjuvant systemic therapy (chemotherapy and/or HER2-targeted therapy) is planned, recruited from the Medical Oncology outpatient clinic at Gazi University Faculty of Medicine Hospital, Ankara, Türkiye.
Cohort
Prospective
Not listed
Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
CTRCD defined per ESC 2022 Cardio-Oncology Guidelines as: an absolute LVEF reduction of ≥10 percentage points to a value below 53%, AND/OR a relative reduction in GLS of ≥15% from baseline. LVEF is measured by transthoracic echocardiography using Simpson's biplane method; GLS is measured by speckle-tracking analysis using a standardized protocol.
Change from baseline in Left Ventricular Ejection Fraction (LVEF)
Absolute change from baseline in left ventricular ejection fraction (LVEF, %) measured by transthoracic echocardiography using Simpson's biplane method. LVEF is the standard echocardiographic parameter for assessing left ventricular systolic function.
Change from baseline in Global Longitudinal Strain (GLS)
Relative change from baseline in Global Longitudinal Strain (GLS, %) measured by speckle-tracking echocardiography. GLS is a sensitive marker of subclinical left ventricular dysfunction that can detect myocardial impairment before changes in LVEF become apparent.
Change in circulating microRNA expression and association with cardiac function
Relative quantification (RQ) of circulating microRNAs (miR-34a, miR-146a, miR-21, miR-155, miR-1, miR-133a, miR-208a, miR-499) measured by quantitative real-time PCR using U6 snRNA as normalization control and analyzed via the 2\^(-ΔΔCt) method. Correlations between miRNA expression changes and LVEF/GLS changes are assessed.
Comparison of CTRCD incidence between anthracycline-containing and anthracycline-free regimens
Frequency of CTRCD (defined as in the primary outcome) compared between patients receiving anthracycline-containing chemotherapy regimens and those receiving anthracycline-free regimens.
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Fatih GURLER
Lead sponsor
Gazi University
Sponsor institution
