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Clinical trial

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

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Last updated:9th Jul 2009
Identifier: NCT00878709

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 2840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: July 9, 2009
Actual Primary Completion Date: August 21, 2014
Estimated Study Completion Date: November 2020

Arms:
- Experimental:
Neratinib
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-05-13
Study type(s) Interventional
Expected enrolment 2840
Study start date 2009-07-09
Estimated primary completion date 2014-08-21

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