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

    Nicholas.Turner@icr.ac.uk

  • Sponsor organisation

    TESARO Inc

  • Eudract number

    2013-000684-85

  • Clinicaltrials.gov Identifier

    NCT01905592

  • 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