Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538896
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Phase II Study of Tislelizumab Combined With Nab-Paclitaxel as First Line Treatment for Patients of Triple-negative Breast CancerTNBC With Bone Metastasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Single-Arm Phase II Study of Tislelizumab Combined With Nab-Paclitaxel as First Line Treatment for Patients of Triple-negative Breast CancerTNBC With Bone Metastasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to learn if Tislelizumab Combined with Nab-Paclitaxel works to treat patients of TNBC with bone metastasis as first line treatment It will also learn about the safety of the combination The main questions it aims to answer are
How effective is the combination therapy of tislelizumab and nab-paclitaxel in treating advanced first-line triple-negative breast cancer with bone metastasis And is it safe
Participants will
Receive the treatment as follows Tislelizumab 200mg intravenous every 3 weeks nab-paclitaxel 125mgm2 on day 1 and day 8 followed by once every three weeks bone targeted therapy selected by investigator
Visit the clinic once every 3 weeks for checkups and tests
Keep a diary of their symptoms and the number of times they use a rescue inhaler
How effective is the combination therapy of tislelizumab and nab-paclitaxel in treating advanced first-line triple-negative breast cancer with bone metastasis And is it safe
Participants will
Receive the treatment as follows Tislelizumab 200mg intravenous every 3 weeks nab-paclitaxel 125mgm2 on day 1 and day 8 followed by once every three weeks bone targeted therapy selected by investigator
Visit the clinic once every 3 weeks for checkups and tests
Keep a diary of their symptoms and the number of times they use a rescue inhaler
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