An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis
Phase of Trial: Phase II
Latest Information Update: 26 Jun 2018
At a glance
- Drugs Neratinib (Primary) ; Budesonide; Colestipol; Loperamide
- Indications Adenocarcinoma; Early breast cancer
- Focus Adverse reactions; Registrational
- Acronyms CONTROL
- Sponsors Puma Biotechnology
- 26 Jun 2018 According to a Puma Biotechnology media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive trend vote recommending the approval of the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer.
- 09 May 2018 Puma Biotechnology expects a re-assessment of the Marketing Authorisation Application for neratinib by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in mid-2018, according to a Company media release.
- 01 Mar 2018 According to a Puma Biotechnology media release, the company expects to report additional data from this trial in the fourth quarter of 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History