ArticleBreast cancer research and treatment2021
Long-term follow-up assessment of cardiac safety in SAFE-HEaRt, a clinical trial evaluating the use of HER2-targeted therapies in patients with breast cancer and compromised heart function.
Article in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- Safety of Permissive Cardiotoxicity of Trastuzumab in Patients with Breast Cancer: A Systematic Review and Meta-Analysis.Cardiovascular toxicology · 2025Pooled it
- Standardizing the Clinical Approach to Cancer Therapy-Related Cardiac Dysfunction: Applying Cardio-Oncology Guidelines as a Practical Tool for Hematology and Oncology Providers.Cancer medicine · 2026Review
- Cardio-Oncology and Heart Failure: a Scientific Statement From the Heart Failure Society of America.Journal of cardiac failure · 2025Review
- Early detection and treatment of cardiac dysfunction in cancer patients improve overall survival.Revista da Associacao Medica Brasileira (1992) · 2025Article
- Cardiovascular Considerations After Cancer Therapy: Gaps in Evidence andJACC. CardioOncology · 2025Review
- Trastuzumab in patients with breast cancer and pre-existing left ventricular systolic dysfunction.Cardio-oncology (London, England) · 2024Article
- Cardiotoxicity of Anticancer Drugs: Molecular Mechanisms, Clinical Management and Innovative Treatment.Drug design, development and therapy · 2024Review
- Competing risk analysis of cardiovascular death in breast cancer: evidence from the SEER database.Translational cancer research · 2023Article
- Cardiotoxicities of Non-Chemotherapeutic Metastatic Breast Cancer Treatments.Current oncology reports · 2023Review
- Review
- Global longitudinal strain in cardio-oncology: worth our trouble or more trouble than it's worth?Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2023Article
- HER2-Directed Therapy in Advanced Breast Cancer: Benefits and Risks.OncoTargets and therapy · 2023Review
- Cardio-oncology in Austria: cardiotoxicity and surveillance of anti-cancer therapies : Position paper of the Heart Failure Working Group of the Austrian Society of Cardiology.Wiener klinische Wochenschrift · 2022Article
- Cardioprotection for Anti-HER2 Therapy: Considerations for Primary Prevention and Use in Mildly Reduced Left Ventricular Ejection Fraction.Current oncology reports · 2022Review
- Cardiotoxicity of Epidermal Growth Factor Receptor 2-Targeted Drugs for Breast Cancer.Frontiers in pharmacology · 2021Review
- Cardiac function in women receiving dual anti-Her2 antibodies (trastuzumab and pertuzumab) combined with chemotherapy for breast cancer.Women's health (London, England)Article
Corrections and comments
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Authors and funding
18 authors at 7 institutions in 1 country.
Funding
Abstract
purposeHER2-targeted therapies are associated with cardiotoxicity which is usually asymptomatic and reversible. We report the updated cardiac safety assessment of patients with compromised heart function receiving HER2-targeted therapy for breast cancer, enrolled in the SAFE-HEaRt trial, at a median follow-up of 3.5 years.
methodsThirty patients with stage I-IV HER2-positive breast cancer receiving trastuzumab with or without pertuzumab, or ado-trastuzumab emtansine (T-DM1), with asymptomatic LVEF (left ventricular ejection fraction) 40-49%, were started on cardioprotective medications, with the primary endpoint being completion of HER2-targeted therapy without cardiac events (CE) or protocol-defined asymptomatic worsening of LVEF. IRB-approved follow-up assessment included 23 patients.
resultsMedian follow-up as of June 2020 is 42 months. The study met its primary endpoint with 27 patients (90%) completing their HER2-targeted therapies without cardiac issues. Of the 23 evaluable patients at long-term f/u, 14 had early stage breast cancer, and 9 had metastatic disease, 8 of whom remained on HER2-targeted therapies. One patient developed symptomatic heart failure with no change in LVEF. There were no cardiac deaths. The mean LVEF improved to 52.1% from 44.9% at study baseline, including patients who remained on HER2-targeted therapy, and those who received prior anthracyclines.
conclusionsLong-term follow-up of the SAFE-HEaRt study continues to provide safety data of HER2-targeted therapy use in patients with compromised heart function. The late development of cardiac dysfunction is uncommon and continued multi-disciplinary oncologic and cardiac care of patients is vital for improved patient outcomes.
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