Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05631795
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2022-11-21
Brief Title:
Study to Assess the Safety of Alpelisib Plus Fulvestrant in Men and Post-menopausal Women With HR-positive HER2-negative Advanced Breast Cancer aBC With PIK3CA Mutation Whose Disease Progressed on or After Endocrine Treatment
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
ALPelisib INdia Safety STudy ALPINIST A Phase IV Prospective Multicenter Open-label Non-comparative Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant in Men and Post-menopausal Women With HR Positive HER2-negative Advanced Breast Cancer aBC With a PIK3CA Mutation Whose Disease Has Progressed on or After Endocrine Based Treatment
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ALPINIST
Brief Summary:
The purpose of this study is to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with HR-positive HER2-negative advanced or metastatic breast cancer aBC with a PIK3CA mutation whose disease has progressed on or after endocrine-based treatment
Detailed Description:
This is a Phase IV prospective multicenter open-label non-comparative interventional study to assess the safety of alpelisib plus fulvestrant in men and post-menopausal women with HR-positive HER2-negative aBC with a PIK3CA mutation whose disease has progressed on or after endocrine-based treatment
Participants will be treated with alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant intramuscular injection 500 mg on Cycle 1 Day 1 and Day 15 and Day 1 of every cycle thereafter in a 28 day cycle Patients may be discontinued from treatment earlier due to unacceptable toxicity disease progression withdrawal of consent or at the discretion of the investigator or the patient
Participants will be treated with alpelisib 300 mg orally once daily starting on Cycle 1 Day 1 in combination with fulvestrant intramuscular injection 500 mg on Cycle 1 Day 1 and Day 15 and Day 1 of every cycle thereafter in a 28 day cycle Patients may be discontinued from treatment earlier due to unacceptable toxicity disease progression withdrawal of consent or at the discretion of the investigator or the patient
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