This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.
Women or men aged 18 or more
Histologically-confirmed advanced breast cancer (metastatic or locally advanced)
Tumor without overexpression of HER2 (HER2 1+ in IHC, or IHC 2+ and FISH/ CISH negative) in samples from the primary and/or secondary tumor
Hormone receptor status known
Prior treatment with a PARP inhibitor and capecitabine for metastatic disease, (Patients treat-ed with these drugs in the adjuvant setting are allowed to participate if they experienced 2 years from end of treatment and metastatic relapse)
Patient has a Dihydropyrimidine dehydrogenase deficiency (DPD)
Patients must not have received anticancer chemotherapy, targeted therapy within 2 weeks prior of the study. Endocrine therapy must have been discontinued 7 or more days before Cycle 1 Day 1. Participant must not have had investigational therapy administered within 4 weeks or with-in a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. Biphosphonates and denosumab are allowed.
Single group
Niraparib Oral Product
DrugNiraparib + capecitabine treatment
Dose-Limiting Toxicities (DLT)
incidence of Dose-Limiting Toxicities (DLT)
efficacy with objective response rate (ORR)
rate of patients experiencing an objective response
adverse events
incidence of adverse events
Pharmacokinetics (PK)
Plasma concentrations and basic PK parameters of niraparib and capecitabine when adminis-tered in combination
Click on the lead sponsor to view all of their trials.
Institut Paoli-Calmettes
Lead sponsor
GlaxoSmithKline
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
