A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
NCT ID: NCT04647487
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
87 participants
INTERVENTIONAL
2021-04-21
2022-11-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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200 milligrams (mg) LY3484356
Participants received 200 mg LY3484356 administered orally once daily for 15 days
LY3484356
Administered orally.
400 mg LY3484356
Participants received 400 mg LY3484356 administered orally once daily for 15 days
LY3484356
Administered orally.
800 mg LY3484356
Participants received 800 mg LY3484356 administered orally once daily for 15 days
LY3484356
Administered orally.
Interventions
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LY3484356
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Winship Cancer Center Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hosptial
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Institut Jules Bordet
Brussel - Capital, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Hôpital René Huguenin
Saint-Cloud, Hauts-de-Seine, France
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Helios Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, Germany
Klinikum der Universitaet Muenchen
München, , Germany
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Madrid Norte Sanchinarro
Madrid, , Spain
The Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Barts Cancer Institute
London, London City, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)
Other Identifiers
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J2J-MC-JZLB
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002810-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17575
Identifier Type: -
Identifier Source: org_study_id