Trial results investigating two standard of care schedules for monitoring cardiac function in patients receiving trastuzumab for early-stage breast cancer were posted on ClinicalTrials.gov on 2025-07-14. The study enrolled 200 participants to compare the impact of these schedules on cardiac outcomes.
Background
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early-stage breast cancer, showing a 33% decrease in the risk of death. However, retrospective analyses have indicated an increased risk of cardiotoxicity, or damage to the heart, in a small number of patients (4-8%). Currently, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications, leading to a standard practice where all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment.
Trial design
This completed Phase 4 study enrolled 200 participants with Breast Cancer. The trial's objective was to compare two standard of care schedules for monitoring cardiac function in patients receiving trastuzumab. The study did not list specific interventions, focusing instead on comparing monitoring schedules.
Key results
The trial collected several key measurements related to cardiac function and treatment management:
- LVEF Results (Median LVEF Percentage change):
- For the LVEF 3 Month monitoring schedule, the median LVEF change was -8 %.
- For the LVEF 4 Month monitoring schedule, the median LVEF change was -6 %.
- Rates of Trastuzumab Delay and Discontinuation (Participants):
- Under the LVEF 3 Month monitoring schedule, one measurement showed 9 participants.
- Under the LVEF 4 Month monitoring schedule, one measurement showed 2 participants.
- A second measurement under the LVEF 3 Month monitoring schedule showed 2 participants.
- A second measurement under the LVEF 4 Month monitoring schedule showed 7 participants.
- Referral to Cardiology (Participants):
- For the LVEF 3 Month monitoring schedule, 12 participants were referred.
- For the LVEF 4 Month monitoring schedule, 12 participants were referred.
- Rate of Cardiac Events (Participants):
- Under the LVEF 3 Month monitoring schedule, 31 participants experienced cardiac events.
- Under the LVEF 4 Month monitoring schedule, 24 participants experienced cardiac events.
A key analysis on the difference in LVEF showed a value of -0.6, with a 95.0% confidence interval ranging from -2.5 to 1.2.
What this means
The key analysis of the difference in LVEF between the two cardiac monitoring schedules indicates no statistically significant difference, as the 95.0% confidence interval (-2.5 to 1.2) crosses zero. While median LVEF changes were observed (-8% and -6% for the respective groups), the comparative analysis suggests similar outcomes regarding LVEF preservation. The data also provides insights into the rates of trastuzumab delay and discontinuation, cardiology referrals, and overall cardiac events, which can inform clinical decisions regarding optimal monitoring frequencies for breast cancer patients receiving trastuzumab.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02696707, titled "An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer", were posted on 2025-07-14 on clinicaltrials.gov.