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New treatment option for Cardiovascular Health
Official title JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
ClinicalTrials.gov ID: NCT06930521
What this study is testing
- What it's testing
- This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Stage 1-3 breast cancer (BC).
- Age 18-79 years.
- HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
You likely can't join if
- Distant metastases detected clinically, radiographically, or histologically
- Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)
- Pre-existing cardiovascular disease, defined as:
- Prior myocardial infarction (even if LVEF has normalized)
- Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)
- Baseline LVEF \<55%
See the full eligibility criteria
- Stage 1-3 breast cancer (BC).
- Age 18-79 years.
- HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
- Distant metastases detected clinically, radiographically, or histologically
- Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)
- Pre-existing cardiovascular disease, defined as:
- Prior myocardial infarction (even if LVEF has normalized)
- Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)
- Baseline LVEF \<55%
- Atrial fibrillation
- Greater than moderate valvular disease (i.e., severe, or moderate-severe)
- Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT
- New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score \>2\
- Symptoms potentially due to serious cardiac disease as per investigator's judgement\ \ Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.