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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04647487
Collaborator
(none)
90
Enrollment
20
Locations
3
Arms
17.9
Anticipated Duration (Months)
4.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Apr 21, 2021
Anticipated Primary Completion Date :
Oct 17, 2022
Anticipated Study Completion Date :
Oct 17, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in ER Expression [Baseline, Day 15]

      ER expression measured by H-score immunohistochemistry (IHC)

    Secondary Outcome Measures

    1. Change from Baseline in Ki-67 Index [Baseline, Day 15]

      Ki-67 index measured by percentage positive scoring by IHC

    2. Change from Baseline in Progesterone Receptor (PR) Expression [Baseline, Day 15]

      PR expression measured by H-score IHC

    3. PK: Plasma Concentration of LY3484356 [Baseline through follow-up at Day 15]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Winship Cancer Center Emory University Atlanta Georgia United States 30322
    2 Northwestern Memorial Hosptial Chicago Illinois United States 60611
    3 Massachusetts General Hospital Boston Massachusetts United States 02114
    4 Washington University School of Medicine Saint Louis Missouri United States 63110
    5 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    6 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    7 Baylor College of Medicine Houston Texas United States 77030
    8 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    9 University of Vermont Medical Center Burlington Vermont United States 05401
    10 Institut Jules Bordet Brussel - Capital Belgium 1070
    11 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium 3000
    12 Hôpital René Huguenin Saint-Cloud Hauts-de-Seine France 92210
    13 Universitätsklinikum Erlangen Erlangen Bayern Germany 91054
    14 Helios Kliniken Schwerin Schwerin Mecklenburg-Vorpommern Germany 19049
    15 Klinikum der Universitaet Muenchen Muenchen Germany 80336
    16 Hospital Clinic I Provincial Barcelona Spain 08036
    17 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    18 Hospital Madrid Norte Sanchinarro Madrid Spain 28050
    19 The Royal Cornwall Hospital Truro Cornwall United Kingdom TR1 3LJ
    20 Barts Cancer Institute London London City United Kingdom EC1A 7BE

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04647487
    Other Study ID Numbers:
    • 17575
    • J2J-MC-JZLB
    • 2020-002810-42
    First Posted:
    Dec 1, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2022