Ignite Creation Date:
2024-05-06 @ 12:41 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03822468
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2019-01-28
Brief Title:
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR HER2- Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Multicenter Randomized Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Status:
COMPLETED
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:
AMALEE
Brief Summary:
QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib The approved dosing regimen of ribociclib is 600 mg daily QD on a 3 weeks on1 week off schedule The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with a non-steroidal aromatase inhibitor NSAI in pre- and postmenopausal women with hormone receptor-positive HR-positive HER2-negative advanced breast cancer aBC who have not received prior therapy for advanced disease
Detailed Description:
This is a phase II multicenter randomized open-label study to evaluate the safety and efficacy of a reduced ribociclib dose of 400 mg in combination with an NSAI letrozole or anastrozole for the treatment of pre- and postmenopausal women with HR-positive HER2-negative aBC who have received no prior therapy for advanced disease
Patients will be randomly assigned to one of the below treatment arms in a 11 ratio
Experimental arm - Ribociclib 400 mg QD 3 weeks on1 week off NSAI goserelin in premenopausal women
Control arm - Ribociclib 600 mg QD 3 weeks on1 week off NSAI goserelin in premenopausal women
Participants will receive study treatment until disease progression radiologically documented according to RECIST 11 criteria unacceptable toxicity death or discontinuation from the study treatment for any other reason Continuation of study treatment beyond initial disease progression RECIST 11 will not be allowed
For participants who discontinue treatment for reasons other than documented disease progression death lost to follow-up or withdrawal of consent tumor assessments must continue to be performed until disease progression death lost to follow-up or withdrawal of consent post-treatment efficacy follow-up
Patients will be randomly assigned to one of the below treatment arms in a 11 ratio
Experimental arm - Ribociclib 400 mg QD 3 weeks on1 week off NSAI goserelin in premenopausal women
Control arm - Ribociclib 600 mg QD 3 weeks on1 week off NSAI goserelin in premenopausal women
Participants will receive study treatment until disease progression radiologically documented according to RECIST 11 criteria unacceptable toxicity death or discontinuation from the study treatment for any other reason Continuation of study treatment beyond initial disease progression RECIST 11 will not be allowed
For participants who discontinue treatment for reasons other than documented disease progression death lost to follow-up or withdrawal of consent tumor assessments must continue to be performed until disease progression death lost to follow-up or withdrawal of consent post-treatment efficacy follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2018-004234-15 | EUDRACT_NUMBER | None | None |