Clinical trial · Interventional
Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab
NCT04429633CI-TRIAL-00045529unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Prevention | — | UNRESOLVED | — |
| Trastuzumab | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Candesartan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Cardiac intervention
- description
- Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.
- interventionNames
- Drug: Candesartan
- type
- ACTIVE_COMPARATOR
- label
- Early Cardiac intervention
- description
- Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.
- interventionNames
- Drug: Candesartan
Primary outcomes (1)
- measure
- Left ventricular ejection fraction (LVEF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.