*Phase III study of Niraparib vs placebo in patients with Breast Cancer
Research type
Research Study
Full title
A Randomized Phase 3 Double-Blinded Study Comparing Efficacy of Niraparib to Placebo in Participants with either HER2-Negative BRCA-Mutated or Triple-negative Breast Cancer with Molecular Disease Based on Presence of Circulating Tumor DNA after Definitive Therapy
IRAS ID
290151
Contact name
Sarah Teale
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2020-003973-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
7 years, 11 months, 25 days
Research summary
For patients with early breast cancer, treatment includes surgical removal of the tumour, with lymph node dissection as required. Although patient survival after surgery can be improved with adjuvant therapy, the risk of recurrence in many patients remains high. Once adjuvant therapy is complete, there is no standard of care for patients with triple negative breast cancer (TNBC) or HER2-Negative BRCA-Mutated breast cancer, beyond clinical monitoring, until disease returns.
Several studies have shown that the presence of circulating tumour DNA (ctDNA) can be predictive of clinical or radiological relapse.
This study is an open label, 2 arm, randomized, Phase 3 trial to compare the efficacy of niraparib (an orally available, potent, highly selective PARP-1 and -2 inhibitor) to placebo in participants with either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer with the presence of ctDNA after definitive therapy. The objective of this study is to evaluate the efficacy of niraparib relative to placebo in delaying the disease returning.
Eligible participants will enter a Pre-screening period for confirmation of detectable ctDNA. This involves a maximum of 4 blood samples over 12m. For participants with detectable ctDNA they will complete a Full Screening visit. Screening will involve a CT or MRI, a bone scan, blood sample collection, vital signs, and a physical exam. Eligible participants will then be randomized in a 1:1 ratio to either niraparib or placebo. Participants will receive either niraparib or placebo daily via a capsule. Participants will be seen every 4 weeks where a blood sample and vital signs will be collected and a number of questionnaires completed. A CT or MRI will be performed every 12 weeks. Participants will be treated until their disease returns or unacceptable side effects. Once treatment has stopped participants will be followed up 3 monthly for survival information for the first 2 years then every 6m thereafter.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/FT/0043
Date of REC Opinion
9 Apr 2021
REC opinion
Further Information Favourable Opinion