Clinical trials / NCT07588425
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Cardiac Side Effects of Systemic Therapy in Early-Stage Breast Cancer

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…

ClinicalTrials.gov IDNCT07588425
PhaseNot Applicable
Enrollment100
SponsorFatih GURLER
Age18 Years
SexFEMALE
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Conditions studied

Breast Cancer (Early Breast Cancer), Cardiotoxicity, Cancer Therapy-Related Cardiac Dysfunction

About this study

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.

Primary outcomes

Eligibility information

Inclusion Criteria: * 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% * Age ≥ 18 years * Able and willing to provide written informed consent Exclusion Criteria: * 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 * Inability or unwillingness to comply with the planned follow-up and assessment schedule

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.