A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

NCT05514054
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
8,000
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Lead sponsor
Eli Lilly and Company
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Start date
2022-10-04
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Number of sites
672
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Summary
The main purpose of this study is 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-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
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Acronym
EMBER-4
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Short title
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
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Official title
EMBER-4: 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-03-01
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First posted
2022-08-24
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Registry last updated
2026-04-02
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Primary completion date
2027-10-01
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Start date
2022-10-04
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Participants
8,000
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Participant count basis
Estimated
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Planned participants
8,000
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Protocol amendments
2
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Number of sites
672
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05514054
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ClinicalTrials.gov ID
NCT05514054
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Invasive Disease-Free Survival (IDFS)

    Timeframe: Randomization to recurrence or death from any cause (up to 10 years)

    IDFS excluding second non-breast primary invasive cancers

  1. Distant Recurrence-Free Survival (DRFS)

    Timeframe: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)

    DRFS

  2. Overall Survival (OS)

    Timeframe: Randomization to Death from Any Cause (up to 10 Years)

    OS

  3. Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant

    Timeframe: Year 1, Month 2 to Month 4

    PK: steady state plasma concentrations of imlunestrant

  4. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning

    Timeframe: Visit 1 Day 1 up to end of Year 5

    The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess multidimensional quality of life (QOL) in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Physical functioning was measured by items 1 to 5. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).

  5. Change from Baseline in the EORTC QLQ-C30 Role Functioning

    Timeframe: Visit 1 Day 1 up to end of Year 5

    The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Role functioning was measured by items 6 and 7. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).

  6. Change from Baseline in the EORTC QLQ-C30 Global QOL

    Timeframe: Visit 1 Day 1 up to end of Year 5

    The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Global QOL was measured by items 29 and 30. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).

  7. Proportion of Time on Study Treatment with High Overall Adverse Event Burden

    Timeframe: Visit 1 Day 1 up to end of Year 5

    FACT GP5 = Functional Assessment of Cancer Therapy - General Physical Well-being Item 5 (FACT GP5). High overall adverse event burden is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • USO - Southern Cancer CenterDaphne, United States
  • Clearview Cancer InstituteHuntsville, United States
  • Infirmary Cancer CareMobile, United States
  • Banner MD Anderson Cancer CenterGilbert, United States
  • USO - Arizona Oncology Associates - HALGlendale, United States
  • St. Joseph's Hospital and Medical CenterPhoenix, United States
  • Mayo Clinic in Arizona - PhoenixPhoenix, United States
  • TMC HealthCareTucson, United States
  • The University of Arizona Cancer Center - North CampusTucson, United States
  • Highlands Oncology GroupSpringdale, United States
  • UCSF - John Muir Health Cancer Center BerkeleyBerkeley, United States
  • Washington HealthFremont, United States
  • Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - IrvineIrvine, United States
  • Loma Linda University Cancer CenterLoma Linda, United States
  • Pacific Cancer CareMonterey, United States
  • St. Joseph HospitalOrange, United States
  • University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, United States
  • University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United States
  • Kaiser Permanente San Diego Mission RoadSan Diego, United States
  • Zuckerberg San Francisco General Hospital and Trauma CenterSan Francisco, United States
  • UCSF Medical Center at Mission BaySan Francisco, United States
  • Saint Joseph's Medical CenterStockton, United States
  • Anschutz Cancer PavilionAurora, United States
  • UCHealth Memorial HospitalColorado Springs, United States
  • UCHealth HarmonyFort Collins, United States

And 647 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2022-501007-28
  • J2J-MC-JZLH
Sources for references
clinicaltrials.gov

Related records

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