Studieoverzicht - 2021-03 EMBER-3

Number 2021-03 EMBER-3
Nickname EMBER-3
Status Open Date: 24-08-2022
Inclusion closed
Other study number(s) J2J-OX-JZLC
Participating parties/groups Lilly Nederland BV
Full title A study of Imlunestrant, Investigator’s choice of Endocrine Therapy, and Imlunestrant plus Abemaciclib in Patients with ER+, HER2- Advanced Breast Cancer
Phase and type Randomized Phase III
Age ≥18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 800 (NL:18)
Actual accrual 815, NL: 3 Date: 08-09-2023
Estimated study completion date 13-09-2026
CCMO approval Yes Date: Nr: NL77553.056.22
EudraCT nr. 2021-000079-35
Trial Register
METC approval Yes Date: 11-07-2022 METC: BEBO Nr:
Amendments Date:
KWF-CKS approval Date: Nr:
News item
Website , voor patienten:
Sponsor Eli Lilly and Company
Principal Investigator(s)
Study manager Eli Lilly Nederland
Central datamanagement and randomization Eli Lilly and Company
Monitoring Eli Lilly and Company
Local datamanagement Eli Lilly and Company
Funding Eli Lilly and Company
Extra De EMBER-3 studie is open in het Maastricht UMC+, MC Leeuwarden en Haga ziekenhuis.


A Phase 3, Randomized, Multi-center, Open-label Study


To assess progression free survival (PFS) 



Progression Free Survival (PFS) 



Overall Survival (OS) 

Objective Response Rate (ORR)

Duration of Response (DoR)

Clinical Benefit Rate (CBR)

PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma

Progression Free Survival (PFS) by blinded independent review

Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" 

Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant

PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib 

Main eligibility criteria:

Main inclusion criteria:

  • Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
  • Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

    - Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed

  • Must be deemed appropriate for treatment with endocrine therapy
  • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
  • Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)


Main exclusion criteria:

  • Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
  • Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
  • Have symptomatic or untreated brain metastasis.
Documents (public):


De verwachting is dat het screenen van patiënten voor de EMBER-3 studie eind september zal sluiten.

Documents (protected):
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