JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Hierarchical composite endpoint encompassing heart health, patient well-being, treatment completion, and imaging frequency in combination, while assessing priority to more important measures.
研究概览
简要总结
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. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine.
The guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs.
To address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective.
The researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 1-3 breast cancer (BC).
- •Age 18-79 years.
- •HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
排除标准
- •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.
研究组 & 干预措施
Standard of Care
The SOC arm will receive imaging before cycles 1, 5, 9, and 13 (in keeping with the FDA product label), then at the end of HER2-TT, i.e., imaging every 3 months for uninterrupted adjuvant HER2TT.
Judicious Imaging
This group will get less echocardiograms based on their risk of developing heart failure. People who do not have any issues that predispose to heart failure are categorized as low risk and will get an echocardiogram once every 6 months. People who have factors that may predispose to heart failure are categorized as intermediate risk and will get an echocardiogram approximately once every 4 months.
干预措施: Intervention - Low Risk Group OR Intermediate Risk Group (Diagnostic Test)
结局指标
主要结局
Hierarchical composite endpoint encompassing heart health, patient well-being, treatment completion, and imaging frequency in combination, while assessing priority to more important measures.
时间窗: From enrollment to the end of treatment at 48 weeks
The primary outcome is a hierarchical composite endpoint for patients with BC receiving HER2-targeted therapy (HER2TT). Participant in the intervention group is compared to participants in the control group based on the following outcomes, in order: 1. Clinically overt heart failure (determined as a binary event Y/N, per standardized definition) 2. Premature discontinuation of HER2TT (determined as a binary event Y/N, per clinical records) 3. Patient-reported outcome measures (PROM) of anxiety/depression, stress and treatment burden: desirable outcome is a better scores in ≥2 of 3 PROMs-Treatment Burden Questionnaire, Hospital Anxiety and Depression Scale, Perceived Stress Scale 4. Asymptomatic cardiotoxicity at end of HER2TT (per criteria, based on LVEF change from baseline to 12 months echocardiograms) 5. Time to complete HER2TT (shorter is better)-number of weeks between 1st and last HER2TT 6. Total cardiac imaging tests during HER2TT (fewer is better)-total assessments of LVEF
次要结局
未报告次要终点
研究者
Husam Abdel-Qadir
Cardiologist
Women's College Hospital