Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133088
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-31
Brief Title:
Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK46 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer a Phase 2 Clinical Trial
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Explore the Efficacy and Safety of Dalpiciclib Combined With Fluvestrant and Compound Gossypol Acetate Tablets in Advanced HR-positive and HER2-negative Breast Cancer After CDK46 Treatment Failed
Status:
RECRUITING
Status Verified Date:
2023-11
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 single-arm Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK46 treatment failed
Detailed Description:
Dalpiciclib According to the standard dose 150mg orally for three weeks and stop for one week
Fluvestrant At the standard dose 500mg once every four weeks A further 500mg dose two weeks after the first dose
Compound gossypol acetate tablets 20mg once a day
Fluvestrant At the standard dose 500mg once every four weeks A further 500mg dose two weeks after the first dose
Compound gossypol acetate tablets 20mg once a day
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