Adjuvant, Breast Cancer, Cardiotoxicity, Prevention, Trastuzumab
Conditions
Brief 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.
Detailed description
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.
Interventions
DRUGCandesartan
If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | at months 3,6,9,12,18 | Maximum change in LVEF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overt chemotherapy induced cardiotoxicity | any time | LVEF \< 45%, decline in LVEF by \>10% to a value to 45-49%, symptomatic congestive heart failure |
| Changes in cardiac biomarker | at months 3,6,9,12,18 | NT-pro BNP, cardiac troponin |
Countries
South Korea
Contacts
Primary ContactYeon Hee Park, MD, PhD
Outcome results
None listed