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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows women with early-stage breast cancer who are receiving standard systemic therapy, including anthracyclines or anti-HER2 agents. Participants undergo echocardiography to measure LVEF and GLS, provide blood samples for microRNA analysis, and complete quality-of-life surveys at four time points (baseline, 3 months, 6 months, and additional time points as per protocol). The goal is to see if GLS changes and circulating microRNAs correlate with early cardiac dysfunction and whether cardiotoxicity risk differs between anthracycline-containing and anthracycline-free regimens. The study addresses gaps in prospective data by combining functional imaging with molecular biomarkers to inform early detection strategies in cardio-oncology.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Fatih Gürler — Gazi University
• Study coordinator: Sıla Soylu Koçoğlu, MD
• Email: drsilasoylu@gmail.com
• Phone: +905012735223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.