Clinical trial · Interventional
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
- 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)
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%). At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment. At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LVEF 3 month | Procedure | — | UNRESOLVED |
| LVEF 4 month | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LVEF 3 month
- description
- cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
- interventionNames
- Procedure: LVEF 3 month
- type
- ACTIVE_COMPARATOR
- label
- LVEF 4 month
- description
- cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
- interventionNames
- Procedure: LVEF 4 month
Primary outcomes (1)
- measure
- LVEF Results
- timeFrame
- Baseline to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed early stage HER2-positive breast cancer * Planned trastuzumab therapy for early stage breast cancer * ≥18 years of age * Able to provide verbal consent * Normal LVEF (\>53%) before trastuzumab therapy Exclusion Criteria: • Contraindication to transthoracic echocardiography or MUGA
References
Publications (1)
- RESULTDent S, Fergusson D, Aseyev O, Stober C, Pond G, Awan AA, McGee SF, Ng TL, Simos D, Vandermeer L, Saunders D, Hilton JF, Hutton B, Clemons M. A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Curr Oncol. 2021 Dec 3;28(6):5073-5083. doi: 10.3390/curroncol28060427. PMID 34940066