Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04303988
Status:
RECRUITING
Last Update Posted:
2020-03-11
First Post:
2020-02-24
Brief Title:
A Phase II Study of Triple-negative Breast Cancer Brain Metastases
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Prospective Single-arm Single-center Phase II Clinical Study of Triple-negative Breast Cancer Brain Metastases
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
NOT_YET_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:
Study to assess the effectiveness and safety of SHR 1316 bevacizumab combined with cisplatincarboplatin for treatment of triple-negative breast cancer brain metastases
Detailed Description:
This is a prospective single-arm single-center Simons two-stage design phase II clinical trial in triple-negative breast cancer brain metastases patients Subjects will receive bevacizumabSHR1316 combined with cisplatincarboplatinand will be treated until disease progression toxicity is intolerable informed consent is withdrawn or investigators determine that medication must be discontinued Drug efficacy and safety data will be collected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