Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02278120
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2014-10-22
Brief Title:
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive HER2-negative Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Randomized Double-blind Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor NSAI and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive HER2-negative Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
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:
MONALEESA-7
Brief Summary:
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors NSAI goserelin LEE011 prolonged progression-free survival PFS compared to treatment with tamoxifen or a NSAI goserelin placebo in premenopausal women with hormone receptor positive HR human epidermal growth factor receptor 2 negative HER2- advanced breast cancer
Detailed Description:
This was a randomized Phase III double-blind global study comparing the treatment efficacy and safety of ribociclib goserelin tamoxifen or a NSAI letrozole or anastrozole versus placebo goserelin tamoxifen or a NSAI in premenopausal women with HR HER2- advanced breast cancer
Eligible participants were randomized in a 11 ratio to either the ribociclib arm or the placebo arm Study treatment continued until disease progression unacceptable toxicity death or discontinuation for any other reason
Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression death withdrawal of consent loss to follow-up or subjectguardian decision post-treatment efficacy follow-up
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival OS events was reached
Following the final OS analysis performed when approximately 189 deaths were recorded and with protocol amendment 6 dated 18-Jul-2019 participants and investigators were unblinded and those participants in the placebo arm had the opportunity to cross-over to the ribociclib arm to receive ribociclib goserelin NSAI Cross-over was optional and was conducted at the investigators discretion and upon participant consent
Eligible participants were randomized in a 11 ratio to either the ribociclib arm or the placebo arm Study treatment continued until disease progression unacceptable toxicity death or discontinuation for any other reason
Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression death withdrawal of consent loss to follow-up or subjectguardian decision post-treatment efficacy follow-up
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival OS events was reached
Following the final OS analysis performed when approximately 189 deaths were recorded and with protocol amendment 6 dated 18-Jul-2019 participants and investigators were unblinded and those participants in the placebo arm had the opportunity to cross-over to the ribociclib arm to receive ribociclib goserelin NSAI Cross-over was optional and was conducted at the investigators discretion and upon participant consent
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 |
|---|---|---|---|
| 2014-001931-36 | EUDRACT_NUMBER | None | None |