Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04967248
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2021-07-08
Brief Title:
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women and Men With HRHER2- Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation After Disease Progression Following Endocrine Therapy as Monotherapy in the Real-world Setting
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Alpelisib Piqray Post-Authorization Safety Study PASS a Non-interventional Study of Alpelisib in Combination With Fulvestrant in Postmenopausal Women and Men With Hormone Receptor Positive HR Human Epidermal Growth Factor Receptor 2 Negative HER2- Locally Advanced or Metastatic Breast Cancer With a Phosphatidylinositol-3-kinase Catalytic Subunit Alpha PIK3CA Mutation After Disease Progression Following Endocrine Therapy as Monotherapy in the Real-world Setting
Status:
RECRUITING
Status Verified Date:
2024-09
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 prospective multi-national non-interventional study NIS collecting data from postmenopausal women and adult men with HR HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy in the real-world setting
Detailed Description:
Once the patient provides informed consent he or she is enrolled in the study Patients will be followed from enrollment until 1 30 days after alpelisib treatment discontinuation or 2 death or 3 lost to follow-up or 4 patient withdrawal or 5 physician decision to end treatmentstudy or 6 end of the study whichever occurs first The end of the study is defined as a maximum of 12 months after the date the last patient was enrolled LPFV if the last patient is still on treatment on that date they will not be followed up any further
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None