RIO - Rucaparib Window of Opportunity Study
Research type
Research Study
Full title
Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)
IRAS ID
154300
Contact name
Nicholas Turner
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2014-003319-12
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Approximately 6,000 women per year in the UK are diagnosed with triple negative breast cancer (TNBC). TNBC makes up 10-15% of all breast cancers. It is a highly proliferative, aggressive form of breast cancer and comes with a high risk of tumour spread and death. Unlike other types of breast cancer, TNBC does not respond to targeted drugs such as those used in hormone therapy or trastuzumab. Chemotherapy is currently the only treatment available and although some patients respond well, those who do not have a poor prognosis.
A family of drugs called PARP inhibitors currently present a promising potential treatment for breast cancer, especially those in the TNBC group. There is also evidence that PARP inhibitors are effective in patients with BRCA1 / BRCA2 related breast cancers.
The aim of the RIO trial is to determine the percentage of primary TNBCs or BRCA1/2 related breast cancers that display sensitivity to the PARP inhibitor rucaparib by measuring change in tumour cells multiplying after 12-14 days of rucaparib treatment. RIO will also aim to identify biomarkers that can identify patient groups sensitive to this medication to allow further analysis of rucaparib in these cancers.
RIO will recruit 91 patients with primary TNBC or known germline BRCA1/2 related primary breast cancer. All patients will receive 2 weeks of treatment with rucaparib in a ‘window of opportunity’ before starting their routine treatment (surgery or neoadjuvant chemotherapy). Research tumour biopsies will be taken at baseline and after 2 weeks of treatment. Patients will be followed up for 28 days after completion of trial treatment.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/2181
Date of REC Opinion
30 Jan 2015
REC opinion
Further Information Favourable Opinion