Studieoverzicht - 2022-05 EMBER-4
Number | 2022-05 EMBER-4 | ||||
Nickname | EMBER-4 | ||||
Status | Open | Date: 03-05-2023 | |||
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 NL: 2 | Date: 12-09-2023 | |||
Estimated study completion date | 31-03-2025 | ||||
CCMO approval | Yes | Date: | Nr: | ||
EudraCT nr. | |||||
Trial Register | NCT05514054 | ||||
METC approval | Yes | Date: | METC: BEBO | Nr: | |
Amendments | Yes | Date: 05-09-2023 | |||
KWF-CKS approval | Not applicable | Date: | Nr: | ||
News item | |||||
Website | , voor patienten: https://www.kanker.nl/trials/1409 | ||||
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-4 studie is open in het Albert Schweitzer ziekenhuis, Amphia ziekenhuis, Deventer ziekenhuis, Haga ziekenhuis, Maastricht UMC+, Reinier de Graaf Gasthuis, Spaarne Gasthuis, VieCuri Medisch Centrum, Zaans Medisch Centrum |
Design:
A Randomized, Open-Label, Multi-center, Phase 3 Study
Objectives:
To measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-).
Endpoints:
Primary:
Invasive Disease-Free Survival
Secondary:
Distant Recurrence-Free Survival
Overall Survival
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Quality of Life
Overall Adverse Event Burden
Main eligibility criteria:
Inclusion Criteria:
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological risk features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate organ function.
Exclusion Criteria:
- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
- Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
- Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
- Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
- Participants with a history of any other cancer.
- Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Documents (public):
De EMBER-4 studie is open in het:
Albert Schweitzer ziekenhuis
Amphia ziekenhuis
Deventer ziekenhuis
Haga ziekenhuis
Maastricht UMC+
Reinier de Graaf Gasthuis
Spaarne Gasthuis
VieCuri Medisch Centrum
Zaans Medisch Centrum
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