About this trial
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.
Eligibility criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Fatih GURLER
Lead sponsor
Gazi University
Sponsor institution