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

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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.

Condition
Breast Cancer (Early Breast Cancer), Cardiotoxicity, Cancer Therapy-Related Cardiac Dysfunction
Sponsor
Fatih GURLER

Who can join

Age
18 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Eligible sex: Female
  • Study condition: Breast Cancer (Early Breast Cancer), Cardiotoxicity, Cancer Therapy-Related Cardiac Dysfunction
  • 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 5

  • 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

1 site, 1 recruiting

Gazi University Faculty of Medicine

Ankara, Ankara, Turkey (Türkiye)

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.