A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2018

At a glance

  • Drugs Neratinib (Primary)
  • Indications Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ExteNET
  • Sponsors Pfizer; Puma Biotechnology; Wyeth
  • Most Recent Events

    • 23 Feb 2018 According to a Puma Biotechnology media release, Based on the results from ExteNET and CONTROL trials, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion, recommending the refusal of the Marketing Authorization Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer. The CHMP has noted that Puma may request a re-examination, a letter of intent to seek re-examination
    • 23 Jan 2018 Based on the results from ExteNET and CONTROL trials, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has communicated a negative trend vote after meeting with the Company to discuss the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer. CHMP will not provide a positive opinion related to the Companys MAA at the formal CHMP decision vote scheduled in February 2018.
    • 13 Dec 2017 According to a Puma Biotechnology media release,EMA has requested that the Scientific Advisory Group on Oncology provide an opinion on the clinical aspects of the MAA for neratinib at a meeting to be held on Jan 11, 2018. CHMP had issued its Day-180 List of Outstanding Issues,company expects to respond by the deadline of Dec 22, 2017.NDA submission was based on the data of Phase III ExteNET and Phase II CONTROL trial.
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