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Updated: Aug 6, 2026

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Published on: August 18, 2023
Cardiac dysfunction associated with trastuzumab
Karen Lisa Smith1, Chau Dang, Andrew D Seidman
1Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA.
Abstract:
The HER2/neu gene is amplified in approximately 25% of breast cancers, leading to HER2 protein overexpression and shortened overall survival and time to relapse. Trastuzumab is a humanised, monoclonal antibody against HER2, which improves survival for women with metastatic HER2-overexpressing breast cancer and reduces the risk of recurrence in women with early stage HER2-overexpressing breast cancer. Cardiac toxicity was an unexpected finding in the pivotal Phase III trial leading to the approval of trastuzumab, and prospective cardiac monitoring has, therefore, been incorporated into more recent clinical trials of trastuzumab. This article reviews the cardiac toxicity findings in key trastuzumab clinical trials and clinical characteristics of trastuzumab-associated cardiac toxicity.
Insights
Trastuzumab, an antibody targeting HER2-positive breast cancer, improves survival but can cause cardiac toxicity. Cardiac monitoring is now standard in clinical trials to manage this side effect.
Area of Science:
- Oncology
- Cardiology
- Pharmacology
Background:
- HER2/neu gene amplification occurs in ~25% of breast cancers, driving tumor progression.
- Trastuzumab is a HER2-targeted therapy improving outcomes in HER2-positive breast cancer.
- Cardiac toxicity is an identified adverse event associated with trastuzumab therapy.
Purpose of the Study:
- To review cardiac toxicity findings in key trastuzumab clinical trials.
- To describe the clinical characteristics of trastuzumab-associated cardiac toxicity.
Main Methods:
- Review of pivotal Phase III clinical trials of trastuzumab.
- Analysis of reported cardiac toxicity data.
- Characterization of clinical presentation and risk factors.
Main Results:
- Trastuzumab significantly improves survival and reduces recurrence in HER2-overexpressing breast cancer.
- Cardiac toxicity emerged as an unexpected adverse event in early trials.
- Prospective cardiac monitoring is now integrated into trastuzumab trials.
Conclusions:
- Trastuzumab is effective for HER2-positive breast cancer but requires cardiac monitoring.
- Understanding trastuzumab-associated cardiac toxicity is crucial for patient management.
- Ongoing research and monitoring are essential for safe and effective HER2-targeted therapy.
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