Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05431504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-06-24
First Post:
2022-06-19
Brief Title:
The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive HER2-negative Advanced Breast Cancer Patients With Visceral Crisis
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
An Exploratory Trial of Dalpiciclib in Combination With Endocrine Therapy in HR-positive HER2-negative Advanced Breast Cancer Patients With Visceral Crisis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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:
None
Brief Summary:
This is a multicenter single-arm open-label Simons two-stage exploratory clinical trial 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I If the study enter stage 2 and continue to include 53 assessable subjects 35 in stage 2 All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression death or intolerable toxicity Tumor assessment was conducted according to RECIST 11 criteria
Detailed Description:
None
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