Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03322215
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2017-09-28
Brief Title:
HRHER2- Advanced Breast Cancer and Endocrine Resistance
Sponsor:
Theodoros Foukakis
Organization:
Karolinska University Hospital
Study Overview
Official Title:
A Phase 2 International Multicenter Open-labeled Randomized Trial of PAlbociclib and Fulvestrant vs Standard Oral Capecitabine In Patients With Hormone Receptor HR HER2- Advanced Breast Cancer and Documented Endocrine Resistance
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASIPHAE
Brief Summary:
This is a randomized 2-arm open-label multicenter international phase II trial A total of 196 patients will be included
The study will include patients with metastatic Hormone Receptor positive Human Epidermal Growth Factor Receptor HER2 negative breast cancer with progressive disease after endocrine treatment
Patients will be randomized 11 between two treatment arms A palbociclib fulvestrant and b capecitabine
The study will include patients with metastatic Hormone Receptor positive Human Epidermal Growth Factor Receptor HER2 negative breast cancer with progressive disease after endocrine treatment
Patients will be randomized 11 between two treatment arms A palbociclib fulvestrant and b capecitabine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None