Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618014
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Neoadjuvant Toripalimab Plus Liposomal Paclitaxel and Carboplatin in Patients With Localized TNBC NeoTOP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Phase II Trial of Neoadjuvant Toripalimab Liposomal Paclitaxel Plus Carboplatin in Patients With Localized Triple-Negative Breast Cancer
Status:
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:
NeoTOP
Brief Summary:
This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus liposomal paclitaxel and carboplatin in patients with localized triple-negative breast cancer
Detailed Description:
Neoadjuvant chemotherapy combined with immunotherapy is the recommended therapeutic approach for patients with localized triple-negative breast cancer TNBC The combination regimen improved the pCR rate of triple negative breast cancer but its side effects also increased In the KEYNOTE-522 trial 78 of patients receiving pembrolizumab combined with anthracycline and paclitaxel chemotherapy experienced grade 3 or higher adverse reactions while the incidence of grade 3 or higher adverse events for patients receiving tislelizumab plus nab-paclitaxel and carboplatin in the CTRIO study was 532 Toripalimab an anti PD-1 monoclonal combined with paclitaxel albumin binding type for first-line treatment of recurrent or metastatic TNBC was recently approved based on the results from the TORCHLIGHT study This study aims to investigate efficacy and safety of neoadjuvant toripalimab plus liposomal paclitaxel and carboplatin in patients with localized TNBC
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