Clinical trial · Interventional
Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
Pilot Study for Optimization of Cardiac Imaging in Women With Early-Stage Breast Cancer
NCT07630402CI-TRIAL-00113827POCEBrecruitingN/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)
The purpose of this study is to determine whether a personalized, risk-stratified surveillance strategy can safely reduce unnecessary cardiac imaging while preserving early detection of treatment-related cardiotoxicity in women with breast cancer (BC) receiving HER2-targeted therapy (HER2-TT).
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 With Low to Intermediate HER2 Expression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Echocardiogram | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard-of-care Group
- description
- Participants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT).
- interventionNames
- Procedure: Echocardiogram
- type
- EXPERIMENTAL
- label
- Judicious-imaging Group
- description
- The Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab).
- interventionNames
- Procedure: Echocardiogram
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex, age 18-79 years. * Histologically confirmed HER2-positive BC scheduled for ≈12 months of adjuvant HER2-TT * Baseline LVEF ≥ 55 % by 2-D echocardiography. * Ability to provide informed consent. Exclusion Criteria: * Prior HF, myocardial infarction, or cardiomyopathy. * Atrial fibrillation or significant valvular heart disease. * Cumulative anthracycline dose ≥ 250 mg/m². * Pregnancy or lactation. * Inability to comply with study procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.