Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404463
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-04
Brief Title:
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ERHER2- 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 ERHER2- Early-Stage Breast Cancer QUEEN-Neo
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-Neo
Brief Summary:
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by ACEC in a neoadjuvant setting in high-risk ERHER2- early breast cancer
Detailed Description:
This study is a single-arm single-center phase II clinical trial aimed at observing and evaluating the effectiveness and safety of QL1706 combined with albumin-bound paclitaxel sequential AC doxorubicincyclophosphamide neoadjuvant therapy for early high-risk ERHER2- breast cancer
A total of 76 subjects are planned to be enrolled After enrollment subjects will receive QL1706 combined with albumin-bound paclitaxel for 4 cycles followed by sequential ACEC treatment for 4 cycles Each treatment cycle will span 3 weeks until the occurrence of a specified treatment termination event after which subjects will continue to undergo postoperative efficacy and safety assessments
Safety assessments will be conducted before each QL1706 treatment cycle Imaging evaluations will be performed every 2 cycles until completion of 8 cycles of treatment to assess efficacy Additional imaging assessments may be performed as clinically indicated during the study Tumor imaging assessments will continue until confirmed disease progression according to RECIST v11 criteria initiation of new anti-tumor therapy withdrawal of consent or death whichever occurs first
Following treatment completion a treatment completion visit will be conducted Subjects who discontinue treatment due to reasons other than RECIST v11-defined disease progression will undergo regular tumor imaging assessment follow-ups to evaluate time to disease progression Subjects will also undergo survival follow-up visits every 6 months every 3 months in the first year and every 6 months thereafter after treatment completion to collect and record survival status and subsequent anti-tumor treatment information
A total of 76 subjects are planned to be enrolled After enrollment subjects will receive QL1706 combined with albumin-bound paclitaxel for 4 cycles followed by sequential ACEC treatment for 4 cycles Each treatment cycle will span 3 weeks until the occurrence of a specified treatment termination event after which subjects will continue to undergo postoperative efficacy and safety assessments
Safety assessments will be conducted before each QL1706 treatment cycle Imaging evaluations will be performed every 2 cycles until completion of 8 cycles of treatment to assess efficacy Additional imaging assessments may be performed as clinically indicated during the study Tumor imaging assessments will continue until confirmed disease progression according to RECIST v11 criteria initiation of new anti-tumor therapy withdrawal of consent or death whichever occurs first
Following treatment completion a treatment completion visit will be conducted Subjects who discontinue treatment due to reasons other than RECIST v11-defined disease progression will undergo regular tumor imaging assessment follow-ups to evaluate time to disease progression Subjects will also undergo survival follow-up visits every 6 months every 3 months in the first year and every 6 months thereafter after treatment completion to collect and record survival status and subsequent anti-tumor treatment information
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