Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038735
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-09-01
Brief Title:
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive HR HER2-negative Advanced Breast Cancer After Treatment With a CDK46 Inhibitor and an Aromatase Inhibitor
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
EPIK-B5 A Phase III Randomized Double-blind Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Who Progressed on or After Aromatase Inhibitor and a CDK46 Inhibitor
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:
EPIK-B5
Brief Summary:
The purpose of this study is to complement Study CBYL719C2301 SOLAR-1 and obtain more comprehensive data on the efficacy and safety of alpelisib BYL719 in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK46 inhibitor
Detailed Description:
This is a Phase III randomized double-blind placebo-controlled international multi-center trial Approximately 234 men and postmenopausal women will be randomized to either alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant Randomization will follow a 11 randomization ratio and be stratified by presence of lung andor liver metastases yes vs no and setting at last prior CDK46 inhibitor therapy adjuvant vs metastatic
Study treatment with alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant will be initiated on Cycle 1 Day 1 and will continue until disease progression per RECIST v11 as per BIRC assessment start of new antineoplastic therapy death lost to follow-up or withdrawal of consent A cycle is defined as 28 days
Participants randomized to the alpelisib-matching placebo plus fulvestrant arm who have disease progression per RECIST v11 as assessed by BIRC will have the option to crossover to be treated with alpelisib plus fulvestrant
Unblinding a single participant at a site will be permitted after disease progression confirmed by BIRC after discussion with the Novartis team to determine eligibility for cross-over to treatment with alpelisib plus fulvestrant
Study treatment with alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant will be initiated on Cycle 1 Day 1 and will continue until disease progression per RECIST v11 as per BIRC assessment start of new antineoplastic therapy death lost to follow-up or withdrawal of consent A cycle is defined as 28 days
Participants randomized to the alpelisib-matching placebo plus fulvestrant arm who have disease progression per RECIST v11 as assessed by BIRC will have the option to crossover to be treated with alpelisib plus fulvestrant
Unblinding a single participant at a site will be permitted after disease progression confirmed by BIRC after discussion with the Novartis team to determine eligibility for cross-over to treatment with alpelisib plus fulvestrant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001966-39 | EUDRACT_NUMBER | None | None |