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 | 443, NL: 1 | Date: 04-01-2023 | |||
| 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: https://www.kanker.nl/trials/1320 | ||||
| Sponsor | Eli Lilly and Company | ||||
| Principal Investigator(s) | ||||
| Study manager | Eli Lilly Nederland |
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| 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)
Primary:
Progression Free Survival (PFS)
Secondary:
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 inclusion criteria:
- Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
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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.
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