Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404736
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Brief Title:
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk TNBC Early-Stage Breast Cancer QUEEN-Dream
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:
QUEEN-Dream
Brief Summary:
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel and carboplatin in a neoadjuvant setting in high-risk TNBC early breast cancer
Detailed Description:
This study is a single-arm single-center phase II clinical study designed to observe and evaluate the efficacy and safety of QL1706 combined with Pcb regimen in the neoadjuvant treatment of early-stage high-risk TNBC breast cancer
It is planned to enroll 73 subjects After the subjects are enrolled in the study they will receive 6 cycles of QL1706 combined with PCb regimen A 3-week treatment cycle is used until the treatment termination event specified in the protocol occurs The subjects will continue to undergo postoperative efficacy and safety visits after ending of the treatment
It is planned to enroll 73 subjects After the subjects are enrolled in the study they will receive 6 cycles of QL1706 combined with PCb regimen A 3-week treatment cycle is used until the treatment termination event specified in the protocol occurs The subjects will continue to undergo postoperative efficacy and safety visits after ending of the treatment
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