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A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)

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ClinicalTrials.gov Identifier: NCT05514054
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Imlunestrant Drug: Tamoxifen Drug: Anastrozole Drug: Letrozole Drug: Exemestane Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2022
Estimated Primary Completion Date : October 15, 2027
Estimated Study Completion Date : March 15, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Imlunestrant
Imlunestrant administered orally.
 Drug: Imlunestrant
Administered orally.
Other Name: LY3484356
Active Comparator: Investigator's Choice of Endocrine Therapy
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
 Drug: Tamoxifen
Administered per local approved label.

Drug: Anastrozole
Administered per local approved label.

Drug: Letrozole
Administered per local approved label.

Drug: Exemestane
Administered per local approved label.


Outcome Measures
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Primary Outcome Measures :
  1. Invasive Disease-Free Survival (IDFS) [ Time Frame: Randomization to recurrence or death from any cause (up to 10 years) ]
    IDFS excluding second non-breast primary invasive cancers


Secondary Outcome Measures :
  1. Distant Recurrence-Free Survival (DRFS) [ Time Frame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) ]
    DRFS

  2. Overall Survival (OS) [ Time Frame: Randomization to Death from Any Cause (up to 10 Years) ]
    OS

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05514054


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05514054    
Other Study ID Numbers: 18459
J2J-MC-JZLH ( Other Identifier: Eli Lilly and Company )
2022-501007-28 ( EudraCT Number )
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Anastrozole
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents