What is the clinical evidence from this study?

Study design: Observational. Population: HER2-positive breast cancer (n=298). Intervention: Trastuzumab. Primary outcome: Cardiotoxicity (risk associated with combined anthracycline therapy) (OR 3.06, 95% CI 1.67-5.62, p=<0.001).

April 26, 2026Frontiers in OncologyOpen Access

Risk factors for trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients

Q: What are the key findings of this study?

Combined anthracycline therapy significantly increased the risk of trastuzumab-induced cardiotoxicity (OR 3.06) in patients with HER2-positive breast cancer.

Q: What question did this study set out to answer?

To identify independent risk factors for trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients to guide early clinical intervention.

View Full Paper

Ask AI

Bookmark

Key result

Combined anthracycline therapy linked to ~206% greater trastuzumab-induced cardiotoxicity risk in HER2-positive breast cancer.

OR 3.06
95% CI 1.67-5.62
P<0.001
n=298

Why the study?

To analyze risk factors for trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients to provide a basis for early clinical intervention.

Key Points

To identify independent risk factors for trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients to guide early clinical intervention.
Conducted a single-center retrospective observational study of N=298 female patients with HER2-positive invasive breast cancer treated with trastuzumab between January 2018 and December 2022, with a median follow-up of 26 months.
Evaluated clinical records including age, hypertension, combined anthracycline regimens, baseline left ventricular ejection fraction (LVEF), and baseline N-terminal pro-brain natriuretic peptide (NT-proBNP), defining cardiotoxicity via 2016 ESC guidelines.
Identified independent predictors of cardiotoxicity using univariate analysis and multivariate logistic regression.
Cardiotoxicity occurred in 65 of 298 patients (21.8%).
Independent clinical risk factors included age ≥60 years (OR = 1.97, 95%CI: 1.21–3.22, P < 0.05), history of hypertension (OR = 2.10, 95%CI: 1.24–3.56, P < 0.05), and combined anthracycline therapy (OR = 3.06, 95%CI: 1.67–5.62, P < 0.05).
Independent biomarker and cardiac function risk factors included baseline NT-proBNP ≥200 pg/ml (OR = 2.34, 95%CI: 1.35–4.05, P < 0.05) and baseline LVEF ≤55% (OR = 2.51, 95%CI: 1.42–4.43, P < 0.05).

Study Design

Type

Observational (n=298)

Multicenter

Structured PICO

Population

298 female patients with HER2-positive primary invasive breast cancer, mean age 52.7 years, single-center (China). Key inclusion: received ≥4 cycles of trastuzumab, baseline LVEF ≥50%, no clinical symptoms of heart failure. Key exclusion: previous other HER2 inhibitors, acute coronary syndrome or stroke within 12 months, severe renal insufficiency (eGFR <30 ml/min/1.73m²), chronic ischemic heart disease, heart failure, or valvular heart disease.

Intervention

Trastuzumab (≥4 cycles, monotherapy or combined with chemotherapy)

Outcome

Trastuzumab-induced cardiotoxicity (defined by 2016 ESC criteria: cardiomyopathy with reduced LVEF, CHF symptoms/signs, or absolute LVEF decrease ≥5% to <55% with symptoms or ≥10% to <55% without symptoms)safety

Main Result

Effect estimate: OR 3.06 (95% CI 1.67-5.62)

p-value: p=<0.001

In HER2-positive breast cancer patients, age ≥60 years, hypertension, combined anthracycline therapy, baseline NT-proBNP ≥200 pg/ml, and baseline LVEF ≤55% are independent risk factors for trastuzumab-induced cardiotoxicity.

Limitations

Retrospective, single-center design inherently limits generalizability and introduces potential selection bias
Did not collect data on cumulative anthracycline dose or detailed cardiovascular medication use
Follow-up duration varied among patients
Absence of central echocardiographic core-lab reading
Substantial proportion (52.7%) had baseline LVEF in the range of 50%–55%, which may represent a population with subclinical cardiac vulnerability
Follow-up duration varied among patients, longer follow-up might capture later-onset cardiotoxicity events
Absence of central echocardiographic core-lab reading may have introduced variability in LVEF measurements

Implication

Supports risk-adapted cardiac monitoring during trastuzumab therapy; leaves open prospective validation before practice adoption.

Abstract

Objective To analyze the risk factors for cardiotoxicity induced by trastuzumab in human epidermal growth factor receptor 2 (HER2) -positive breast cancer patients and provide a basis for early clinical intervention. Methods A retrospective analysis was conducted on 298 HER2-positive breast cancer patients treated with trastuzumab. Clinical data including age, history of cardiovascular disease, combined chemotherapy regimens, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, and baseline left ventricular ejection fraction (LVEF) were collected. Multivariate logistic regression was used to identify independent risk factors for cardiotoxicity. Results A total of 65 patients (21.8%) developed cardiotoxicity. Multivariate analysis showed that age ≥60 years (OR = 1.97, 95%CI: 1.21–3.22), history of hypertension (OR = 2.10, 95%CI: 1.24–3.56), combined anthracycline therapy (OR = 3.06, 95%CI: 1.67–5.62), baseline NT-proBNP ≥200 pg/ml (OR = 2.34, 95%CI: 1.35–4.05), and baseline LVEF ≤55% (OR = 2.51, 95%CI: 1.42–4.43) were independent risk factors for trastuzumab-induced cardiotoxicity (all P < 0.05). Conclusion These findings enable risk stratification before trastuzumab initiation. Future research should validate a predictive model incorporating these factors and assess cardioprotective strategies, thereby translating risk assessment into actionable protocols to optimize cardiac safety without compromising oncologic outcomes.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Zhang et al. (2026) conducted an observational in HER2-positive breast cancer (n=298). Trastuzumab was evaluated on Cardiotoxicity (risk associated with combined anthracycline therapy) (OR 3.06, 95% CI 1.67-5.62, p=<0.001). Combined anthracycline therapy significantly increased the risk of trastuzumab-induced cardiotoxicity (OR 3.06) in patients with HER2-positive breast cancer.

synapsesocial.com/papers/69edaa9b4a46254e215b32a4 https://doi.org/10.3389/fonc.2026.1819766

View Full Paper

Ask AI

Bookmark

Implication

Supports risk-adapted cardiac monitoring during trastuzumab therapy; leaves open prospective validation before practice adoption.

Risk factors for trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Risk factors for trastuzumab-induced cardiotoxicity in HER2-positive breast cancer patients

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading