Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05392608
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2022-05-16
Brief Title:
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer SEQUEL-Breast
Sponsor:
Borstkanker Onderzoek Groep
Organization:
Borstkanker Onderzoek Groep
Study Overview
Official Title:
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer SEQUEL-Breast A Phase 2 Study on Fulvestrant Beyond Progression in Combination With Alpelisib for PIK3CA-mutated Hormone-receptor Positive HER2 Negative Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-10
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:
SEQUEL-Breast
Brief Summary:
The study is a nationwide multicenter single-arm phase 2 study The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant either in first or second line with or without previous use of CDK46-inhibitor in patients with HR HER2- advanced breast cancer with PIK3CA mutated tumors
All eligible patients must have progressive disease on fulvestrant as latest treatment line
Previous treatment with a CDK46 inhibitor in first or second line is obligatory After progressive disease is confirmed it is important to continue fulvestrant without CDK46 inhibition during the screening period awaiting study enrollment
After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression Follow-up time will be until progression or death or until a different oncolytic treatment has started in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented
Should participants discontinue due to reasons other than progression or death eg toxicity then they should still be evaluated for disease progression every 8 weeks as per protocol until progression unless they do not wish to proceed with these screenings or receive a different oncolytic treatment
All eligible patients must have progressive disease on fulvestrant as latest treatment line
Previous treatment with a CDK46 inhibitor in first or second line is obligatory After progressive disease is confirmed it is important to continue fulvestrant without CDK46 inhibition during the screening period awaiting study enrollment
After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression Follow-up time will be until progression or death or until a different oncolytic treatment has started in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented
Should participants discontinue due to reasons other than progression or death eg toxicity then they should still be evaluated for disease progression every 8 weeks as per protocol until progression unless they do not wish to proceed with these screenings or receive a different oncolytic treatment
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