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

Description

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.

Conditions

Breast Neoplasms

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Neoplasms
Intervention / Treatment

-

Contacts and Locations

Daphne

USO - Southern Cancer Center, Daphne, Alabama, United States, 36526

Huntsville

Clearview Cancer Institute, Huntsville, Alabama, United States, 35805

Mobile

Infirmary Cancer Care, Mobile, Alabama, United States, 36607

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Glendale

USO - Arizona Oncology Associates - HAL, Glendale, Arizona, United States, 85308

Phoenix

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, 85004

Phoenix

Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona, United States, 85054

Tucson

USO - Arizona Oncology Associates - HOPE, Tucson, Arizona, United States, 85711

Tucson

The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States, 85719

Springdale

Highlands Oncology Group, Springdale, Arkansas, United States, 72762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2032-03-15