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

Documents (protected):
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