Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04856371
Status:
UNKNOWN
Last Update Posted:
2021-04-23
First Post:
2021-04-11
Brief Title:
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR HER2- Advanced Breast Cancer
Sponsor:
Haihe Biopharma Co Ltd
Organization:
Haihe Biopharma Co Ltd
Study Overview
Official Title:
A Multicenter Open-label Phase Ib Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With PIK3CA Mutant HR HER2- Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2021-03
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:
This is a multicenter open-label phase Ib study designed to evaluate the safety tolerability pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET CDK46 inhibitor therapies for the treatment of locally advanced recurrent or metastatic hormone-receptor positive HR human epidermal growth factor receptor 2 negative HER2- breast cancer Patients will be enrolled in two stages including dose exploration phase Stage 1 and dose expansion phase Stage 2 of each cohort
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