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)
60
Enrollment
21
Locations
2
Arms
11
Anticipated Duration (Months)
2.9
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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 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 :
Mar 21, 2022
Anticipated Study Completion Date :
Mar 21, 2022

Arms and Interventions

ArmIntervention/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
  • 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:
    Participant Must:
    • 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

    Exclusion Criteria:
    Participant Must Not:
    • 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)

    • Be pregnant or breastfeeding

    • Have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled

    • Have another serious medical condition

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Cedars Sinai Medical CenterLos AngelesCaliforniaUnited States90048
    2Winship Cancer Center Emory UniversityAtlantaGeorgiaUnited States30322
    3Northwestern Memorial HosptialChicagoIllinoisUnited States60611
    4Massachusetts General HospitalBostonMassachusettsUnited States02114
    5Washington University School of MedicineSaint LouisMissouriUnited States63110
    6Sarah Cannon Research Institute SCRINashvilleTennesseeUnited States37203
    7Tennessee Oncology PLLCNashvilleTennesseeUnited States37203
    8Baylor College of MedicineHoustonTexasUnited States77030
    9University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030
    10University of Vermont Medical CenterBurlingtonVermontUnited States05401
    11Institut Jules BordetBrusselBelgium1000
    12Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuvenBelgium3000
    13Hôpital René HugueninSaint-CloudHauts-de-SeineFrance92210
    14Universitätsklinikum ErlangenErlangenBayernGermany91054
    15Klinikum der Universität MünchenMünchenBayernGermany80337
    16Helios Kliniken SchwerinSchwerinMecklenburg-VorpommernGermany19049
    17Hospital Clinic I ProvincialBarcelonaSpain08036
    18Hospital General Universitario Gregorio MarañonMadridSpain28007
    19Hospital Madrid Norte SanchinarroMadridSpain28050
    20The Royal Cornwall HospitalTruroCornwallUnited KingdomTR1 3LJ
    21Barts Cancer InstituteLondonLondon CityUnited KingdomEC1A 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:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021