Clinical trial · Observational
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients
A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer
NCT03983382CI-TRIAL-00111716active not recruitingResults postedClinicalTrials.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 test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Left Ventricular Ejection Fraction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2-Positive Breast Cancer
- interventionNames
- Diagnostic Test: Left Ventricular Ejection Fraction
Primary outcomes (1)
- measure
- Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.
- timeFrame
- 12 months from baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years * Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV) * Pathologically confirmed HER2-positive breast cancer * Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months. * Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal) * William and able to comply with the requirements of the protocol Exclusion Criteria: * Planned to receive an anthracycline-based regimen * Prior history of treatment with anthracycline chemotherapy * History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator) * Uncontrolled hypertension, defined as systolic blood pressure \>/= 160 mmHg and/or diastolic blood pressure \>/= 90 mmHg (as determined by the investigator)
References
Publications (1)
- DERIVEDYu AF, Dang CT, Jorgensen J, Moskowitz CS, DeFusco P, Oligino E, Oeffinger KC, Liu JE, Steingart RM. Rationale and design of a cardiac safety study for reduced cardiotoxicity surveillance during HER2-targeted therapy. Cardiooncology. 2023 Mar 9;9(1):13. doi: 10.1186/s40959-023-00163-4. PMID 36895062