Overview

Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer

Status:
Recruiting
Trial end date:
2023-07-18
Target enrollment:
0
Participant gender:
Female
Summary
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Candesartan
Criteria
Inclusion Criteria:

- Female aged ≥ 18 years

- Pathologically confirmed HER2-positive breast cancer

- Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab

- Baseline echocardiogram should be performed before starting trastuzumab

- Cumulative anthracycline dose ≤ 300mg/m2

- Written informed consent to participate in the study

Exclusion Criteria:

- History of hypersensitivity or alllergic reaction to the study medication

- Metastatic breast cancer

- Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor
blocker (ARB), beta-blocking agents, or diuretics

- Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction,
symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate),
arrhythmias (Grade ≥ 3) < 12 months before enrollment

- Pregnancy or breast feeding

- Baseline systolic pressure < 90mmHg

- Cumulative anthracycline dose > 300mg/m2

- Serious concurrent illness