Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05485766
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2022-08-01
Brief Title:
Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 12 Mutated Triple Negative Breast Cancer
Sponsor:
Okayama University
Organization:
Okayama University
Study Overview
Official Title:
Neoadjuvant and Adjuvant Olaparib Plus Pembrolizumab Following Platinum Based Chemotherapy Plus Pembrolizumab for Germline BRCA Mutated Triple Negative Breast Cancer WJOG14020BOPERETTA
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
This is a Phase II single-arm open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA gBRCA 12 mutated triple negative breast cancer TNBC
Pembrolizumab in combination with weekly paclitaxel and carboplatin treatment 1 is followed by Pembrolizumab in combination with Olaparib treatment 2 in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied
Pembrolizumab in combination with weekly paclitaxel and carboplatin treatment 1 is followed by Pembrolizumab in combination with Olaparib treatment 2 in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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