| Number |
2022-05 EMBER-4 |
| Nickname |
EMBER-4 |
| Status |
Submitted (METC) |
Date: 23-02-2023 |
| Inclusion closed |
|
| Other study number(s) |
|
| Participating parties/groups |
Eli Lilly |
| Full title |
A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence |
| Phase and type |
Randomized Phase III |
| Age |
≥18 |
| Menopausal status |
Both pre- and postmenopausal |
| Indication |
Adjuvant |
| Subindication |
HER2- HR+ |
| Target sample size |
6000 (NL:70) |
| Actual accrual |
In andere landen: 29 |
Date: 23-02-2023 |
| Estimated study completion date |
31-03-2025 |
| CCMO approval |
Yes |
Date: |
Nr: |
| EudraCT nr. |
|
| Trial Register |
NCT05514054 |
| METC approval |
Yes |
Date: |
METC:
|
Nr: |
| Amendments |
|
Date: |
| KWF-CKS approval |
Not applicable |
Date: |
Nr: |
| News item |
|
| Website |
|
| Sponsor |
Lilly |
| Principal Investigator(s) |
|
| Study manager |
|
| Central datamanagement and randomization |
|
| Monitoring |
|
| Local datamanagement |
|
| Funding |
|
| Extra |
|
Design:
Objectives:
Endpoints:
Main eligibility criteria:
Documents (public):
Protocol synopsis
Documents (protected):
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