Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733417
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2020-12-30
Brief Title:
A Study of SHR6390 Combined With Famitinib in the Treatment of HR HER2- Advanced Breast Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
An Exploratory Study of CDK46 Inhibitor SHR6390 Combined With Famitinib in the Treatment of HR HER2- Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The study is being conducted to assess the efficacy and safety of SHR6390 combined with famitinib in the treatment of advanced or metastatic breast cancer that progress in 1-2 line endocrine therapy
Detailed Description:
This is a single-center single-arm open-label Simons two-stage design phase II clinical trial The purpose of this study was to evaluate the efficacy and safety of SHR6390 combined with famitinib in the treatment of HRHER2 advanced or metastatic breast cancer patients who have progressed during or after 1-2 line endocrine therapy Subjects will be treated until disease progression toxicity is intolerable informed consent is withdrawn and investigators determine that medication must be discontinued Drug efficacy and safety data will be collected
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