Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05128773
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
2021-11-10
Brief Title:
Study of Amcenestrant SAR439859 Versus Tamoxifen for Patients With Hormone Receptor-positive HR Early Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Multicenter Double-blind Phase 3 Study of Amcenestrant SAR439859 Versus Tamoxifen for the Treatment of Patients With Hormone Receptor-positive Human Epidermal Growth Factor Receptor 2-negative or Positive Stage IIB-III Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to prematurely stop the study not linked to any safety concern
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMEERA-6
Brief Summary:
This was a phase III randomized double blind multicenter 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who discontinued adjuvant aromatase inhibitor AI therapy due to treatment related toxicity The primary objective was to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival
The treatment duration per participant was to be 5 years followed with a subsequent 5-years follow-up period For the treatment period visits were scheduled at the start of treatment then at 4 weeks and 12 weeks after treatment start and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5 For the follow-up period visits were scheduled 30 days after last treatment and then every 12 months Three periods were planned
A screening period of up to 28 days
A treatment period of up to 5 years
A follow-up period of up to 5 years
The treatment duration per participant was to be 5 years followed with a subsequent 5-years follow-up period For the treatment period visits were scheduled at the start of treatment then at 4 weeks and 12 weeks after treatment start and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5 For the follow-up period visits were scheduled 30 days after last treatment and then every 12 months Three periods were planned
A screening period of up to 28 days
A treatment period of up to 5 years
A follow-up period of up to 5 years
Detailed Description:
Study duration per participant was to be approximately 10 years
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 |
|---|---|---|---|
| 2021-000398-10 | EUDRACT_NUMBER | EORTC | None |
| U1111-1244-1767 | REGISTRY | None | None |
| BIG 20-01 | OTHER | None | None |
| AFT-55 | OTHER | None | None |
| EORTC-2033 | OTHER | None | None |