Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407310
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-04
Brief Title:
Neoadjuvant Pembrolizumab Carboplatin and Paclitaxel in Triple-negative Breast Cancer
Sponsor:
Tel Aviv Medical Center
Organization:
Tel Aviv Medical Center
Study Overview
Official Title:
Phase II Open-label Single-arm Trial of Neoadjuvant Pembrolizumab With Carboplatin and Paclitaxel in Triple-negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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-centered open-label single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response pCR rate of a non-anthracycline-based chemo-immunotherapy regimen The trial includes a lead-in cycle of pembrolizumab then a combination of paclitaxel carboplatin and pembrolizumab in the neoadjuvant setting
Detailed Description:
The cure rate of stage I and II triple-negative breast cancer treated with anthracycline-based chemotherapy is high but comes at the price of substantial toxicity This is a phase II single-centered open-label single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response pCR rate and immune effects of a non-anthracycline-based chemo-immunotherapy regimen The trial includes a lead-in cycle of pembrolizumab then a combination of paclitaxel carboplatin and pembrolizumab in the neoadjuvant setting
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?:
False
Is an FDA AA801 Violation?:
None