Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT04478266
Status:
TERMINATED
Last Update Posted:
2025-09-11
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMEERA-5
Brief Summary:
Primary Objective:
To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.
Secondary Objective:
* To compare the overall survival in both treatment arms.
* To evaluate the objective response rate in both treatment arms.
* To evaluate the duration of response in both treatment arms.
* To evaluate the clinical benefit rate in both treatment arms.
* To evaluate progression-free survival on next line of therapy.
* To evaluate the pharmacokinetics of amcenestrant, and palbociclib.
* To evaluate health-related quality of life in both treatment arms.
* To evaluate the time to first chemotherapy in both treatment arms.
* To evaluate safety in both treatment arms.
To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.
Secondary Objective:
* To compare the overall survival in both treatment arms.
* To evaluate the objective response rate in both treatment arms.
* To evaluate the duration of response in both treatment arms.
* To evaluate the clinical benefit rate in both treatment arms.
* To evaluate progression-free survival on next line of therapy.
* To evaluate the pharmacokinetics of amcenestrant, and palbociclib.
* To evaluate health-related quality of life in both treatment arms.
* To evaluate the time to first chemotherapy in both treatment arms.
* To evaluate safety in both treatment arms.
Detailed Description:
Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
Study Oversight
Has Oversight DMC:
True
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?: