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A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3)

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ClinicalTrials.gov Identifier: NCT04975308
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : August 9, 2022
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, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoplasm Metastasis Drug: Imlunestrant Drug: Exemestane Drug: Fulvestrant Drug: Abemaciclib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : June 13, 2023
Estimated Study Completion Date : September 13, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

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 exemestane administered orally or fulvestrant administered intramuscularly (IM).
 Drug: Exemestane
Administered orally.

Drug: Fulvestrant
Administered IM.
Experimental: Imlunestrant plus Abemaciclib
Imlunestrant plus abemaciclib administered orally.
 Drug: Imlunestrant
Administered orally.
Other Name: LY3484356

Drug: Abemaciclib
Administered orally.
Other Name: LY2835219


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) ]
    PFS by investigator assessment


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization until death from any cause (estimated as up to 5 years) ]
    OS

  2. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]
    ORR

  3. Duration of Response (DoR) [ Time Frame: Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years) ]
    DoR

  4. Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks [ Time Frame: Randomization until measured progressive disease (estimated as up to 1 year) ]
    CBR

  5. PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years) ]
    Investigator-assessed PFS by ESR1 mutation status in plasma

  6. Progression Free Survival (PFS) [ Time Frame: Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years) ]
    PFS by blinded independent review

  7. Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" [ Time Frame: Screening through follow-up (estimated as up to 3 years) ]
    Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."

  8. Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant [ Time Frame: Cycle 2 to Cycle 4 (cycle = 28 days) ]
    PK: steady state plasma concentrations of imlunestrant

  9. PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib [ Time Frame: Cycle 2 to Cycle 4 (cycle = 28 days) ]
    PK: steady state plasma concentrations of imlunestrant and abemaciclib


Eligibility Criteria
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Information from the National Library of Medicine

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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- locally advanced or metastatic breast cancer

  • 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)
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
  • Have adequate renal, hematologic, and hepatic organ function
  • Must be able to swallow capsules/tablets

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.
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
  • Known allergic reaction against any of the components of the study treatment
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): NCT04975308


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: NCT04975308    
Other Study ID Numbers: 18175
J2J-OX-JZLC ( Other Identifier: Eli Lilly and Company )
2021-000079-35 ( EudraCT Number )
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
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
Keywords provided by Eli Lilly and Company:
SERD
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Fulvestrant
Exemestane
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action