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A Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

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Trial Profile

A Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Feb 2023

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At a glance

  • Drugs Fulvestrant (Primary) ; Neratinib (Primary) ; Trastuzumab (Primary)
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Proof of concept; Therapeutic Use
  • Acronyms MutHER

    • Most Recent Events

    • 01 Feb 2023 According to a Puma Biotechnology media release, The updated NCCN Practice Guidelines for Breast Cancer include neratinib combinations as category 2B potential targeted therapies for patients with ER+/HER2- or ER-/HER2- metastatic (stage IV) breast cancer and activating mutations in the HER2 gene as detected by next generation sequencing of tumor tissue or ctDNA. Neratinib is included 1) with or without fulvestrant, and 2) with or without trastuzumab/fulvestrant.
    • 01 Feb 2023 According to a Puma Biotechnology media release, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer were updated to include an addition involving neratinib (NERLYNX), based on results from SUMMIT and MutHER trials.
    • 19 Jan 2022 Results assessing efficacy of neratinib plus fulvestrant in patients with ER+/HER2mut, HER2-non-amplified metastatic breast cancer (MBC) published in the Clinical Cancer Research
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