JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention - Low Risk Group OR Intermediate Risk Group: Participants will be randomized to judicious imaging (decreased imaging frequency based on HF risk category) or SOC (imaging every 3 months). Participants who do not have any HF risk factors will be categorized as low risk, while participants with at least one risk factor will be categorized as intermediate risk for HF. Low Risk (zero risk factors): imaging before cycles 1 and 9 of HER2-TT (i.e., at baseline and near the halfway mark, corresponding to 2 fewer studies than SOC in Year 1), then after the end of HER2TT. This translates to imaging every 6 months for uninterrupted adjuvant HER2TT. Intermediate Risk (any risk factors): imaging before cycles 1, 6, and 12 of HER2-TT (i.e., at baseline and near the 1/3 and 2/3 marks, corresponding to 1 fewer study than SOC in Year 1), then at end of HER2TT. This translates to imaging every 4 months for uninterrupted adjuvant HER2TT.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Clinically overt heart failure — From enrollment to <100days after end of treatment
  Determined as a binary event Y/N, per standardized definition
• Premature HER2TT discontinuation — From enrollment to <100days after end of treatment
  Determined as a binary event Y/N, per clinical records
• Patient-reported outcome measures (PROMS) of anxiety/depression, stress, and treatment burden — From enrollment to <100 days after end of treatment
  Desirable outcome is a better scores in ≥2 of 3 PROMs-Treatment Burden Questionnaire, Hospital Anxiety and Depression Scale, Perceived Stress Scale
• Asymptomatic cardiotoxicity at end of HER2TT — From enrollment to <100 days after the end of treatment
  Per Cardiac Review and Evaluation Committee criteria, based on LVEF change
• Time to complete HER2TT — From enrollment to <100 days after the end of treatment
  Number weeks from first HER2TT cycle to last (shorter is better)
• Total number of cardiac imaging tests during HER2TT — From enrollment to <100 days after the end of treatment
  Number of LVEF assessments (fewer is better)

Trial sites (1)

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