Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02941926
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2016-10-20
Brief Title:
Study to Assess the Safety and Efficacy of Ribociclib LEE011 in Combination With Letrozole for the Treatment of Men and PrePostmenopausal Women With HR HER2- aBC
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
COMPLEEMENT-1 An Open-label Multicenter Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib LEE011 in Combination With Letrozole for the Treatment of Men and PrePostmenopausal Women With Hormone Receptor-positive HR HER2-negative HER2- Advanced Breast Cancer aBC With no Prior Hormonal Therapy for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2023-10
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:
COMPLEEMENT-1
Brief Summary:
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib letrozole in men and prepostmenopausal women with HRHER2- advanced breast cancer and no prior hormonal treatment for advanced disease
Detailed Description:
This was an open-label single arm multi-center Phase IIIb study The study was composed of 2 phases Core Phase and Extension Phase In the Core Phase safety and efficacy data was collected The study treatment during the Core Phase was provided until disease progression death unacceptable toxicities physicians decision subjectguardians decision protocol deviation study termination by sponsor lost to follow-up technical problems or up to 18 months after LPFV
In the event that patients were still deriving benefit at the end of the Core phase and ribociclib was not approved or available and reimbursed patients were transitioned to the Extension Phase and continued to receive study treatment until progression intolerance death or physicianpatient decision Only safety and clinical benefit as assessed by investigator data was collected in the Extension Phase During the Extension Phase if ribociclib became locally approved and reimbursed patients were to be transitioned to prescription Patients who completed the Extension Phase and continued to derive clinical benefit from the treatment based on the investigators evaluation received ribociclib from prescription if approved and reimbursed another post-trial access program or other drug accesssupport programs
Canadian sub-study this sub-study was a multicenter Canadian exploratory correlative sample collection sub-study that aimed to better understand mechanisms of response and resistance to ribociclib in combination with letrozole therapy This sub-study was available for all Canadian subjects enrolled on the main study and did not alter the planned treatment
In the event that patients were still deriving benefit at the end of the Core phase and ribociclib was not approved or available and reimbursed patients were transitioned to the Extension Phase and continued to receive study treatment until progression intolerance death or physicianpatient decision Only safety and clinical benefit as assessed by investigator data was collected in the Extension Phase During the Extension Phase if ribociclib became locally approved and reimbursed patients were to be transitioned to prescription Patients who completed the Extension Phase and continued to derive clinical benefit from the treatment based on the investigators evaluation received ribociclib from prescription if approved and reimbursed another post-trial access program or other drug accesssupport programs
Canadian sub-study this sub-study was a multicenter Canadian exploratory correlative sample collection sub-study that aimed to better understand mechanisms of response and resistance to ribociclib in combination with letrozole therapy This sub-study was available for all Canadian subjects enrolled on the main study and did not alter the planned treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-003467-19 | EUDRACT_NUMBER | None | None |