Trial reportCurrent oncology (Toronto, Ont.)2021
A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer.
Trial report in Current oncology (Toronto, Ont.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02696707 (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), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Time to Personalize Surveillance for Cancer Therapy-Related Cardiac Dysfunction in HER2-Targeted Therapy: One Size Does Not Fit All.Current heart failure reports · 2026Review
- Adjuvant Weekly Paclitaxel and Trastuzumab for HER2-Positive Early-Stage Breast Cancer with Preserved Baseline LVEF: Incidence of Cardiotoxicity and Feasibility of Simplified Cardiac Surveillance.Breast cancer (Dove Medical Press) · 2026Article
- The Rethinking Clinical Trials (REaCT) Program: A Pragmatic Research Strategy to Improve Cancer Care for Patients, Caregivers, and Healthcare Systems.Current oncology (Toronto, Ont.) · 2025Review
- Cardiac Safety of Reduced Cardiotoxicity Surveillance During HER2-Targeted Therapy.JACC. CardioOncology · 2025Article
- Shorter Durations of Anti-HER2 Therapy for Patients with Early-Stage, HER2-Positive Breast Cancer: The Physician Perspective.Current oncology (Toronto, Ont.) · 2023Article
- Evolving Role of Risk Tailored Therapy in Early Stage HER2-Positive Breast Cancer: A Canadian Perspective.Current oncology (Toronto, Ont.) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe optimal frequency for cardiac monitoring of left ventricular ejection fraction (LVEF) in patients receiving trastuzumab-based therapy for early breast cancer (EBC) is unknown. We conducted a randomized controlled trial comparing 3- versus 4-monthly cardiac monitoring. PATIENTS AND
methodPatients scheduled to receive trastuzumab-containing cancer therapy for EBC with normal (>53%) baseline LVEF were randomized to undergo LVEF assessments every 3 or 4 months. The primary outcome was the change in LVEF from baseline. Secondary outcomes included the rate of cardiac dysfunction (defined as a decrease in the LVEF of ≥10 percentage points, to a value <53%), delays in or discontinuation of trastuzumab therapy, and cardiology referral.
resultsOf the 200 eligible and enrolled patients, 100 (50%) were randomized to 3-monthly and 100 (50%) to 4-monthly cardiac monitoring. Of these patients, 98 and 97 respectively underwent at least one cardiac scan. The estimated mean difference in LVEF from baseline was -0.94% (one-sided 95% lower bound: -2.14), which exceeded the pre-defined non-inferiority margin of -4%. There were also no significant differences between the two study arms for any of the secondary endpoints. The rate of detection of cardiac dysfunction was 16.3% (16/98) and 12.4% (12/97) in the 3- and 4-monthly arms, respectively (95% CI: 4.0 [-5.9, 13.8]).
conclusionsCardiac monitoring every 4 months was deemed non-inferior to that every 3 months in patients with HER2-positive EBC being treated with trastuzumab-based therapy. Given its costs and inconvenience, cardiac monitoring every 4 months should be considered standard practice. Registration: NCT02696707, 18 February 2016.
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