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: 09 Aug 2017

At a glance

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

    • 09 Aug 2017 According to a Puma Biotechnology media release, the company expects to report final 5-year disease free survival (DFS) data in the third half of 2017.
    • 17 Jul 2017 According to a FDA media release, the US FDA has approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer based on the results of this trial.
    • 24 May 2017 According to a Puma Biotechnology media release, U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 - 4 to recommend approval of PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top