Clinical trial · Observational
Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
- 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 introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes. However, cardiac toxicity remains a substantial concern. Conventionally, this toxicity has been considered as a transient and reversible phenomenon occurring in the immediate peri-treatment period in around 20% of patients. Current guidelines recommend monitoring heart function during treatment and at completion. Recent registry data suggest that trastuzumab-related cardiotoxicity may also manifest in the longer-term. The nature and longer-term prevalence of left ventricular dysfunction with HER2 positive breast cancer treated with trastuzumab is unclear. The aim of this project is to define the prevalence of left ventricular dysfunction late after completion of trastuzumab therapy.
Conditions
Conditions (3)
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 |
| Cardiotoxicity | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Participants with previous HER2 breast cancer
- label
- Healthy Volunteers
Primary outcomes (3)
- measure
- Left Ventricular Systolic Dysfunction
- timeFrame
- Through study completion, on average <2years.
- description
- To define the prevalence of left ventricular dysfunction in patients who received trastuzumab chemotherapy at least 5 years previously
- measure
- Reduced Global Longitudinal Strain (global and segmental)
- timeFrame
- Through study completion, on average <2years.
- description
- GLS less than 2 standard deviations from normal reference range, using Displacement Encoding with Stimulated Echoes (DENSE) MRI.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with HER2 positive breast cancer who received anthracycline-containing chemotherapy followed by trastuzumab at least 5 years prior to enrolment; * age \>18 years. Exclusion Criteria: * standard contraindication to CMR (ex: pacemaker, metallic implant); * pregnancy; * eGFR \<30 ml/min/1.73 m2) past medical history of heart failure or left ventricular systolic dysfunction. Healthy Volunteers: Twenty age and sex matched healthy volunteers will undergo a similar CMR protocol. Inclusion Criteria: * least 18 years (they will be matched to the study participants) * no prior medical history (including cardiovascular health problems, medication or systemic illness) Exclusion Criteria: * standard contraindication to CMR; * suspected pregnancy
References
Publications (0)
Data not yet available