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Exploring Off-Label HER2-Targeted Therapy in Early Breast Cancer

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Some clinicians are incorporating off-label HER2-targeted therapies in select early breast cancer patients, particularly when high-risk features or residual disease after standard therapy are present. The rationale for this approach is often grounded in emerging clinical trial data, real-world experience, or extrapolation from metastatic disease studies, suggesting potential benefits in reducing recurrence or improving pathologic response. Off-label use is generally considered when standard therapies may be insufficient, or when novel agents show promising activity in related disease settings. While these strategies can offer patients additional options, clinicians must carefully weigh efficacy against potential toxicity and consider the lack of formal regulatory approval. Ongoing research and evolving guideline recommendations are expected to clarify which early breast cancer populations may benefit most from such off-label HER2-targeted interventions.

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