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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04647487
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
Breast Cancer Drug: LY3484356 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 21, 2021
Estimated Primary Completion Date : October 17, 2022
Estimated Study Completion Date : October 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3484356 Dose Level 1
Administered orally.
 Drug: LY3484356
Administered orally.
Other Name: Imlunestrant
Experimental: LY3484356 Dose Level 2
Administered orally.
 Drug: LY3484356
Administered orally.
Other Name: Imlunestrant
Experimental: LY3484356 Dose Level 3
Administered orally.
 Drug: LY3484356
Administered orally.
Other Name: Imlunestrant


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in ER Expression [ Time Frame: Baseline, Day 15 ]
    ER expression measured by H-score immunohistochemistry (IHC)


Secondary Outcome Measures :
  1. Change from Baseline in Ki-67 Index [ Time Frame: Baseline, Day 15 ]
    Ki-67 index measured by percentage positive scoring by IHC

  2. Change from Baseline in Progesterone Receptor (PR) Expression [ Time Frame: Baseline, Day 15 ]
    PR expression measured by H-score IHC

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647487


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04647487    
Other Study ID Numbers: 17575
J2J-MC-JZLB ( Other Identifier: Eli Lilly and Company )
2020-002810-42 ( EudraCT Number )
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases