Studieoverzicht - 2022-05 EMBER-4

 
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
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Protocol synopsis

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