ArticleOncology and therapy2025
A Retrospective Observational Study of Extended Adjuvant Neratinib for HER2-Positive Early-Stage Breast Cancer in a European Early Access Program.
Article in Oncology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05599334 (A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program (NEAR)
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13 authors.
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Abstract
introductionNeratinib is approved in Europe as extended adjuvant therapy in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (EBC) who completed adjuvant trastuzumab-based therapy within 1 year. Real-world data are necessary to define the role of neratinib in the evolving treatment landscape.
methodsNEAR was a retrospective, observational study evaluating treatment patterns, safety and effectiveness of neratinib during a European early access program (EAP). Eligible patients had HER2+ EBC and received neratinib between August 2017 and December 2020. Data were extracted from medical records up to July 2022. The primary endpoint was the patient demographic and clinical profile.
resultsAmong 108 eligible patients, most had HR+ disease (n = 92) and a high risk of recurrence (defined as stage II-III or node-positive disease, or non-pathological complete response after neoadjuvant therapy; n = 87); 74 were treated as per the neratinib European label. Trastuzumab plus pertuzumab and trastuzumab alone were the most common anti-HER2+ adjuvant therapies (9.3% and 88.4% of patients, respectively). Median duration of neratinib treatment was 12.3 months. Diarrhoea was the most common adverse event (58.3%). Prophylactic anti-diarrhoeal therapy reduced the occurrence of grade ≥ 3 diarrhoea (4.3% versus 13.2% without prophylaxis) and neratinib discontinuation (22.2% versus 35.7%, respectively). Exploratory invasive disease-free survival rates were 93.3% at 24 months and 89.9% at 36 months, with no central nervous system events.
conclusionThese results provide additional data supporting the safety and exploratory effectiveness of neratinib in the EAP, reflecting real-world clinical practice. CLINICALTRIALS: GOV IDENTIFIER: NCT05599334 (31 October 2022, retrospectively registered).
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