Niraparib vs. physician choice in HER2 negative breast cancer
Research type
Research Study
Full title
A phase III, randomised, open label, multicentre, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients
IRAS ID
137994
Contact name
Nicholas Turner
Contact email
Sponsor organisation
TESARO Inc
Eudract number
2013-000684-85
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to compare the effects of treating patients with either niraparib (the study drug) or physician’s choice of standard chemotherapy for women suffering from HER -2 negative breast cancer that has spread (metastatic).
The study drug, niraparib, belongs to a category of drugs known as PARP inhibitors. Recent clinical studies have shown PARP inhibitors to be active in several other tumour types including breast cancer. These drugs have the potential to selectively kill cancer cells by affecting DNA repair mechanisms. This means that patients who carry a certain mutation called BRCA1 or BRCA2, are more likely to respond to the experimental drug niraparib as they cannot repair DNA defects.
Due to the fact that nirapirab is given orally and the different treatments given as part of physician’s choice have various modes of administration, this study will be open-label. This means that both participants and the study doctor will know to which treatment arm the participant is assigned.
The study is being sponsored by Tesaro, Inc (the “sponsor”) and is being conducted in collaboration with the Breast International Group (BIG) and the European Organisation for Research and Treatment of Cancer (EORTC). The sponsor plans to enrol 306 participants into this study.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0089
Date of REC Opinion
15 Apr 2014
REC opinion
Further Information Favourable Opinion