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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History