Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03386162
Status:
TERMINATED
Last Update Posted:
2022-11-28
First Post:
2017-12-21
Brief Title:
SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
A Phase II Randomized Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy as Maintenance Therapy in Patients With PIK3CA Mutated Advanced Breast Cancer
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was halted Prematurely for low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFIR-PI3K
Brief Summary:
SAFIR PI3K is an open-label multicenter phase II randomized trial comparing alpelisib plus fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HRHer2- metastatic breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line chemotherapy
The primary objective is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival PFS compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive HR HER2-negative advanced breast cancer who do not present a progressive disease after 6-8 cycles of chemotherapy
The primary objective is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival PFS compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive HR HER2-negative advanced breast cancer who do not present a progressive disease after 6-8 cycles of chemotherapy
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