Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533384
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-06
Brief Title:
PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PARPi or Capecitabine Combined With PD-1 Inhibitors Was Selected Based on the Germline BRCA12 Mutation vs PD-1 Inhibitors Alone as Adjuvant Therapy in High-risk Non-pCR TNBC
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In TNBC patients who have completed neoadjuvant immunotherapy and local treatment a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach Based on the classification according to their BRCA mutation status patients with BRCA mutations choose the PD-1 inhibitor PARPi regimen while patients without BRCA mutations opt for the PD-1 inhibitor capecitabine regimen Compared to monotherapy with PD-1 inhibitors these combination regimens may offer improved efficacy and acceptable tolerability This study is designed as a prospective randomized controlled open-label single-center phase III trial aimed at assessing the efficacy and safety of selecting PARPi or capecitabine in combination with PD-1 inhibitors based on germline BRCA12 mutations as adjuvant therapy in high-risk TNBC patients who have achieved non-pCR after completion of neoadjuvant immunotherapy in conjunction with chemotherapy and local treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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