A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)

March 29, 2023 updated by: Eli Lilly and Company

EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer

The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel - Capital, Belgium, 1070
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • France
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92210
        • Hôpital René Huguenin
  • Germany
      • Muenchen, Germany, 80336
        • Klinikum der Universitaet Muenchen
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitatsklinikum Erlangen
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19049
        • HELIOS Kliniken Schwerin
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • The Royal Cornwall Hospital
    • London City
      • London, London City, United Kingdom, EC1A 7BE
        • Barts Cancer Institute
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Center Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hosptial
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute SCRI
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Have histologically confirmed invasive ER+, HER2- breast carcinoma
  • Be willing and able to provide pre- and on-treatment tumor samples
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
  • Have adequate organ function
  • Be able to swallow capsules
  • Be a postmenopausal woman

Exclusion Criteria:

  • Have bilateral invasive breast cancer
  • Have metastatic breast cancer
  • Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy
  • Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer
  • Have had prior radiotherapy to the ipsilateral chest wall for any malignancy
  • Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer
  • Have had prior hormone-replacement therapy within 4 weeks of the start of study treatment
  • Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s)
  • Have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
  • Have another serious medical condition
  • Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3484356 Dose Level 1
Administered orally.
Drug: LY3484356
Administered orally.
Other Names:
  • Imlunestrant
Experimental: LY3484356 Dose Level 2
Administered orally.
Drug: LY3484356
Administered orally.
Other Names:
  • Imlunestrant
Experimental: LY3484356 Dose Level 3
Administered orally.
Drug: LY3484356
Administered orally.
Other Names:
  • Imlunestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in ER Expression
Time Frame: Baseline, Day 15
ER expression measured by H-score immunohistochemistry (IHC)
Baseline, Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Ki-67 Index
Time Frame: Baseline, Day 15
Ki-67 index measured by percentage positive scoring by IHC
Baseline, Day 15
Change from Baseline in Progesterone Receptor (PR) Expression
Time Frame: Baseline, Day 15
PR expression measured by H-score IHC
Baseline, Day 15
PK: Plasma Concentration of LY3484356
Time Frame: Baseline through follow-up at Day 15
Baseline through follow-up at Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

November 11, 2022

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17575
  • J2J-MC-JZLB (Other Identifier: Eli Lilly and Company)
  • 2020-002810-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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