Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01905592
Status:
TERMINATED
Last Update Posted:
2022-11-15
First Post:
2013-07-18
Brief Title:
A Phase III Trial of Niraparib Versus Physicians Choice in HER2 Negative Germline BRCA Mutation-positive Breast Cancer Patients
Sponsor:
Tesaro Inc
Organization:
Tesaro Inc
Study Overview
Official Title:
A Phase III Randomized Open Label Multicenter Controlled Trial of Niraparib Versus Physicians Choice in Previously-treated HER2 Negative Germline BRCA Mutation-positive Breast Cancer Patients
Status:
TERMINATED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAVO
Brief Summary:
The purpose of this study is to compare progression-free survival PFS in patients with advancedmetastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physicians choice
Detailed Description:
This is a phase III randomized open label multicenter controlled trial of niraparib versus physicians choice in previously-treated HER2 negative germline BRCA mutation-positive breast cancer patients Niraparib is an orally active PARP inhibitor Niraparib in a 21 ratio will be administered once daily continuously during a 21-day cycle Physicians 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1307-BCG BIG5-13 | OTHER | None | None |
| PR-30-5010-C | OTHER | Tesaro | None |