An observational study to describe the population of patients treated with extended adjuvant neratinib.

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Retrospective observational study of adult patients with early-stage HER-2 positive breast cancer, treated with neratinib as extended adjuvant therapy in the context of the European Early Access Program.

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Brief summary

HER2+ breast cancer is a subtype of breast cancer which represents approximately 15% to 25% of breast cancer worldwide.

In patients with early-stage HER2+ breast cancer, a pivotal clinical study demonstrated that the use neratinib (Nerlynx®), following (neo)adjuvant trastuzumab based therapy, improves clinical outcomes of patients.

In this context, the purpose of this observational retrospective study is to describe the population of patients in Europe who were treated with extended adjuvant neratinib after having received a trastuzumab based therapy*.

*Trastuzumab based therapy = treatment with trastuzumab combined with chemotherapy, with or without pertuzumab, or treatment with trastuzumab emtansine and being part of the reference treatment for adjuvant (= post surgery) therapy of HER2+ breast cancer.

Therapeutic area :
Disease :
Breast cancer
Study medication :
Neratinib (NERLYNX®)
Phase : RWE
Start Date :
July 2022
End Date / Planned study Completion Date :
July 2023
Study ID : NIS12501 Number : NCT05599334
Countries :

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