Clinical trial · Observational
Cardiac Side Effects of Systemic Therapy in Early-Stage Breast Cancer
Prospective and Molecular Biomarker-Based Evaluation of Cardiac Side Effects in Patients With Early-Stage Breast Cancer Receiving Systemic Therapy: A Single-Center Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate cardiac side effects in women with early-stage breast cancer who receive systemic chemotherapy and/or anti-HER2 therapy as part of their standard cancer care. The main questions it aims to answer are: Can changes in Global Longitudinal Strain (GLS) on echocardiography detect early cardiac dysfunction before a drop in left ventricular ejection fraction (LVEF) becomes apparent? Are changes in circulating microRNA levels in the blood associated with early cardiac dysfunction during cancer treatment? Does cardiac dysfunction occur more frequently with anthracycline-containing chemotherapy compared to anthracycline-free regimens? Participants already receiving standard chemotherapy and/or anti-HER2 therapy as part of their routine cancer care will undergo echocardiography (LVEF and GLS), provide blood samples for microRNA analysis, and complete quality of life questionnaires at four time points: before treatment (baseline), and at 3, 6, and 12 months after starting treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer (Early Breast Cancer) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Cancer Therapy-Related Cardiac Dysfunction | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Early-stage breast cancer patients receiving systemic therapy
- description
- Adult women with histologically confirmed Stage I-III breast cancer for whom neoadjuvant or adjuvant chemotherapy and/or HER2-targeted systemic therapy is planned, with baseline left ventricular ejection fraction ≥ 50%. Patients receive standard-of-care systemic therapy as determined by their treating oncologist; the study does not modify treatment selection, dose, or duration. For analytic purposes, patients are sub-grouped by chemotherapy regimen (anthracycline-containing vs. anthracycline-free) for comparative analyses of cardiac function and circulating microRNA changes.
Primary outcomes (1)
- measure
- Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
- timeFrame
- From baseline through Month 12
- description
- CTRCD defined per ESC 2022 Cardio-Oncology Guidelines as: an absolute LVEF reduction of ≥10 percentage points to a value below 53%, AND/OR a relative reduction in GLS of ≥15% from baseline. LVEF is measured by transthoracic echocardiography using Simpson's biplane method; GLS is measured by speckle-tracking analysis using a standardized protocol.
Secondary outcomes (11)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of breast cancer * Stage I, II, or III disease * Planned neoadjuvant or adjuvant chemotherapy and/or HER2-targeted systemic therapy * Baseline transthoracic echocardiographic left ventricular ejection fraction (LVEF) ≥ 50% * Age ≥ 18 years * Able and willing to provide written informed consent Exclusion Criteria: * Metastatic (Stage IV) breast cancer * Pre-existing heart failure or clinically significant cardiac disease * Prior exposure to chemotherapy or other cardiotoxic systemic therapy * Concurrent active malignancy other than breast cancer * Inability or unwillingness to comply with the planned follow-up and assessment schedule
References
Publications (6)
- RESULTLyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available. PMID 36017568
- RESULTKuang Z, Ge Y, Cao L, Wang X, Liu K, Wang J, Zhu X, Wu M, Li J. Precision Treatment of Anthracycline-Induced Cardiotoxicity: An Updated Review. Curr Treat Options Oncol. 2024 Aug;25(8):1038-1054. doi: 10.1007/s11864-024-01238-9. Epub 2024 Jul 27. PMID 39066853
- RESULTPoovorawan N, Susiriwatananont T, Teerapakpinyo C, Chariyavilaskul P, Sitthideatphaiboon P, Jarutasnangkul L, Tumkosit M, Chattranukulchai P, Theerasuwipakorn N, Aporntewan C, Shuangshoti S, Manasnayakorn S, Vinayanuwattikun C, Vorasettakarnkij Y, Sriuranpong V. Long-term impact of anthracycline in early-stage breast cancer, bridging of MiRNAs profiler for early cardiotoxicity. Cardiooncology. 2025 Apr 23;11(1):39. doi: 10.1186/s40959-025-00337-2. PMID 40270054
- RESULTBoen HM, Cherubin M, Franssen C, Gevaert AB, Witvrouwen I, Bosman M, Guns PJ, Heidbuchel H, Loeys B, Alaerts M, Van Craenenbroeck EM. Circulating MicroRNA as Biomarkers of Anthracycline-Induced Cardiotoxicity: JACC: CardioOncology State-of-the-Art Review. JACC CardioOncol. 2024 Feb 27;6(2):183-199. doi: 10.1016/j.jaccao.2023.12.009. eCollection 2024 Apr. PMID 38774014
- RESULTMecinaj A, Gulati G, Ree AH, Gravdehaug B, Rosjo H, Steine K, Wisloff T, Geisler J, Omland T, Heck SL. Impact of the ESC Cardio-Oncology Guidelines Biomarker Criteria on Incidence of Cancer Therapy-Related Cardiac Dysfunction. JACC CardioOncol. 2024 Jan 16;6(1):83-95. doi: 10.1016/j.jaccao.2023.10.008. eCollection 2024 Feb.