|

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

RECRUITINGSponsored by Fatih GURLER
Actively Recruiting
SponsorFatih GURLER
Started2026-05-11
Est. completion2027-12-10
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions6

Breast CancerBreast Cancer, Early Breast CancerCancerCancer Therapy-related Cardiac DysfunctionCardiotoxicityHeart Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.