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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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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Neoplasm Metastasis
Breast Neoplasms

Treatments

Drug: Imlunestrant
Drug: Abemaciclib
Drug: Fulvestrant
Drug: Exemestane

Study type

Interventional

Funder types

Industry

Identifiers

NCT04975308
18175
J2J-OX-JZLC (Other Identifier)
2021-000079-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

866 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

866 participants in 3 patient groups

Imlunestrant
Experimental group
Description:
Imlunestrant administered orally.
Treatment:
Drug: Imlunestrant
Investigator's Choice of Endocrine Therapy
Active Comparator group
Description:
Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.
Treatment:
Drug: Exemestane
Drug: Fulvestrant
Imlunestrant plus Abemaciclib
Experimental group
Description:
Imlunestrant plus abemaciclib administered orally.
Treatment:
Drug: Abemaciclib
Drug: Imlunestrant

Trial contacts and locations

245

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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