Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Mili Arora (ucdavis)

Description

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.

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

Keywords

Breast Neoplasms, Neoplasm Metastasis, SERD, Neoplasms, Fulvestrant, Exemestane, Imlunestrant, Abemaciclib, Imlunestrant plus Abemaciclib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Davis - Health Systems accepting new patients
    Sacramento California 95817 United States
  • Sharp Memorial Hospital not yet accepting patients
    San Diego California 92123 United States
  • Marin Cancer Care accepting new patients
    Greenbrae California 94904 United States

Lead Scientist at University of California Health

  • Mili Arora (ucdavis)
    Assistant Professor, Hematology and Oncology, School of Medicine. Authored (or co-authored) 10 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT04975308
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 860 study participants
Last Updated