Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2-related breast cancer.
Disease site: Breast cancer
Treatment modality: Systemic therapy
Status: In follow up
RIO is a single group, open label, multicentre, phase II window study to assess the proportion of patients with primary triple negative breast cancers and germline BRCA1/2-related primary breast cancers that demonstrate sensitivity to the PARP inhibitor rucaparib.
91 patients will be recruited from approximately 12 UK sites over a period of 18 months. 81 patients will have primary, triple negative breast cancer of unknown BRCA1/2 mutation status at trial entry.
A further 10 patients recruited will have known germline BRCA1/2-related primary breast cancer at trial entry. All patients entering the trial will receive rucaparib (600 mg, twice daily) for 12–14 days. Following completion of rucaparib treatment, patients will proceed to standard care and followed up for 28 days.
Chief Investigator: Professor Nicholas Turner, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: firstname.lastname@example.org
Sponsor: The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust
Funding: Clovis Pharmaceuticals and endorsed by Cancer Research UK’s Clinical Trials Advisory and Awards Committee (CRUK/12/034)
Further information including recruitment progress is available from the following link:
View RIO on the National Institute for Health Research website: NIHR - Be Part Of Research
A plain English summary of the TNT trial is available from Cancer Research UK.
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