1905592
Last Update Posted: 2022-11-15
Recruiting has ended
All Genders accepted | 18 Years + |
216 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
This is a phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician's choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients. Niraparib is an orally active PARP inhibitor. Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of life will be measured. The safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.
Eligibility
Relevant conditions:
Neoplasms, Breast
Carcinoma of Breast
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ovarian Neoplasms
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov