A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

Last updated: October 22, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

1

Condition

Breast Cancer

Cancer

Treatment

LY3484356

Clinical Study ID

NCT04647487
17575
J2J-MC-JZLB
2020-002810-42
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Have bilateral invasive breast cancer

  • Have metastatic breast cancer

  • Plan to receive concurrent neoadjuvant therapy with any other non-protocolanti-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, aromataseinhibitor, or other selective estrogen receptor modulator (SERM), either forosteoporosis or prevention of breast cancer

  • Have had prior hormone-replacement therapy within 4 weeks of the start of studytreatment

  • Have had major surgery within 28 days prior to randomization to allow forpost-operative healing of the surgical wound and site(s)

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

  • Have another serious medical condition

  • Have a history of any other cancer (except nonmelanoma skin cancer or carcinomain-situ of the cervix), unless in complete remission with no therapy for a minimumof 3 years

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: LY3484356
Phase: 1
Study Start date:
April 21, 2021
Estimated Completion Date:
November 11, 2022

Connect with a study center

  • Institut Jules Bordet

    Brussel, 1000
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Brussel - Capital, 1070
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Hôpital René Huguenin

    Saint-Cloud, Hauts-de-Seine 92210
    France

    Site Not Available

  • Hôpital René Huguenin

    Saint-Cloud 2981041, Hauts-de-Seine 92210
    France

    Site Not Available

  • Centre Rene Huguenin - Institut Curie

    Saint Cloud, 92210
    France

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen 2929567, Bavaria 2951839 91054
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Klinikum der Universität München Großhadern

    München, Bayern 80337
    Germany

    Site Not Available

  • Helios Kliniken Schwerin

    Schwerin, Mecklenburg-Vorpommern 19049
    Germany

    Site Not Available

  • Helios Kliniken Schwerin

    Schwerin 2834282, Mecklenburg-Vorpommern 2872567 19049
    Germany

    Site Not Available

  • Klinikum der Universitaet Muenchen

    Muenchen, 80336
    Germany

    Site Not Available

  • Klinikum der Universitaet Muenchen

    München 2867711, 80336
    Germany

    Site Not Available

  • Hospital Clinic I Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic I Provincial

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Hospital Madrid Norte Sanchinarro

    Madrid 3117735, 28050
    Spain

    Site Not Available

  • The Royal Cornwall Hospital

    Truro, Cornwall TR1 3LJ
    United Kingdom

    Site Not Available

  • The Royal Cornwall Hospital

    Truro 2635412, Cornwall TR1 3LJ
    United Kingdom

    Site Not Available

  • Barts Cancer Institute

    London, London City EC1A 7BE
    United Kingdom

    Site Not Available

  • Barts Cancer Institute

    London 2643743, London City EC1A 7BE
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, Scotland EH4 2XU
    United Kingdom

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Winship Cancer Center Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Winship Cancer Center Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Northwestern Memorial Hosptial

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hosptial

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology PLLC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute SCRI

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington 5234372, Vermont 5242283 05401
    United States

    Site Not Available

  • University of Wisconsin-Madison Hospital and Health Clinic

    Madison, Wisconsin 53792-4108
    United States

    Site Not Available

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