Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04524000
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2020-08-19
Brief Title:
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Open-label 2-Part Multi-center Study of BYL719 Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With PIK3CA Mutation Hormone Receptor HR Positive HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor AI Treatment in Japan
Status:
ACTIVE_NOT_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:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor HR positive human epidermal growth factor 2 HER2-negative advanced breast cancer harboring a PIK3CA mutation in Japan whose disease has progressed on or after aromatase inhibitor AI treatment regardless of prior CDK46 inhibitor use
Detailed Description:
This is a Phase II open-label 2-Part multi-center study in Japan The study will be conducted in two parts Part 1 Cohort 1 includes participants regardless of prior CDK46 inhibitor use and is designed to determine the recommended dose RD evaluate the tolerability and safety of alpelisib in combination with fulvestrant Part 2 consists of 2 cohorts the CDK46 inhibitor naive participants are in Cohort 2 and the CDK46 inhibitor pre-treated participants are in Cohort 3 which are designed to assess the efficacy and safety of alpelisib in combination with fulvestrant will start once the RD of alpelisib is established
Participants will be treated until disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason and will be followed for survival regardless of treatment discontinuation reason except if consent is withdrawn or participant is lost to follow up
Participants will be treated until disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason and will be followed for survival regardless of treatment discontinuation reason except if consent is withdrawn or participant is lost to follow up
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