Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04915755
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-08
First Post:
2021-06-01
Brief Title:
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative HER2- Breast Cancer Susceptibility Gene Mutation BRCAmut or Triple-Negative Breast Cancer TNBC With Molecular Disease
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety 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 ZEST
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEST
Brief Summary:
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene tBRCAmut HER2- breast cancer Independent of hormone receptor HR status including HR positive and TNBC or tumor BRCA wild type tBRCAwt TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid ctDNA following surgery or completion of adjuvant therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2020-003973-23 | EUDRACT_NUMBER | None | None |