Cardiac Side Effects of Systemic Therapy in Early-Stage Breast Cancer

Starting soon

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

In brief

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.

Key facts

Study ID

NCT07588425

Run by

Fatih GURLER

People needed

100

Starts

2026-05-10

Expected to finish

2028-03-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Gazi University Faculty of Medicine — Ankara, Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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