Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637306
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Neoadjuvant Dupilumab Pembrolizumab Paclitaxel and Carboplatin in Locally Advanced Triple Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab Paclitaxel and Carboplatin in Locally Advanced Triple Negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab paclitaxel and carboplatin in locally advanced triple negative breast cancer TNBC
Primary Objective To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events irAEs in patients with locally advanced TNBC
Secondary Objectives To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab to determine the rate of residual cancer burden 0-1 to estimate the recurrence-free survival and overall survival to assess the toxicity of the combination of dupilumab pembrolizumab and paclitaxel-carboplatin
Primary Objective To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events irAEs in patients with locally advanced TNBC
Secondary Objectives To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab to determine the rate of residual cancer burden 0-1 to estimate the recurrence-free survival and overall survival to assess the toxicity of the combination of dupilumab pembrolizumab and paclitaxel-carboplatin
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