Neratinib after Trastuzumab in early stage breast cancer.
Research type
Research Study
Full 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.
IRAS ID
27111
Contact name
Anjana Anand
Eudract number
2008-007345-31
Clinicaltrials.gov Identifier
Research summary
This study is looking at a new treatment for breast cancer versus placebo in women with early-stage breast cancer. A placebo looks like the tablets under investigation but does not contain any active medicine.As of October 24th 2011, 2842 subjects were randomly assigned in a 1:1 ratio to 1 of the following 2 arms: Neratinib daily for 1 year and Placebo daily for 1 year. After discontinuing study treatment, subjects will continue to be followed to see how they are and whether the disease has come back (known as disease recurrence), up to approximately 2 years after starting the study. The primary objective of this study is to compare disease free survival (DFS) (the length of time after treatment during which a patient survives) of women receiving neratinib versus disease free survival of women receiving placebo following trastuzumab (Herceptin) treatment given after surgery (called adjuvant therapy). The women recruited to the study have early stage Her 2 positive over expressed/amplified breast cancer. Her2 (also called erbB-2) is a protein which controls cell growth and Her2 positive patients usually have breast cancers which grow and spread more quickly. Women in this study have breast cancer in which the cells have a high level of Her2 protein (called over expressed/amplified). Enrolment is now completed but the study will be ongoing until 2013.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
09/H0405/44
Date of REC Opinion
9 Oct 2009
REC opinion
Further Information Favourable Opinion