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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 : Not yet recruiting
First Posted : December 1, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 30, 2020
First Posted Date  ICMJE December 1, 2020
Last Update Posted Date April 8, 2021
Estimated Study Start Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
Change from Baseline in ER Expression [ Time Frame: Baseline, Day 15 ]
ER expression measured by H-score immunohistochemistry (IHC)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2020)
  • Change from Baseline in Ki-67 Index [ Time Frame: Baseline, Day 15 ]
    Ki-67 index measured by percentage positive scoring by IHC
  • Change from Baseline in Progesterone Receptor (PR) Expression [ Time Frame: Baseline, Day 15 ]
    PR expression measured by H-score IHC
  • PK: Plasma Concentration of LY3484356 [ Time Frame: Baseline through follow-up at Day 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: LY3484356
Administered orally.
Study Arms  ICMJE
  • Experimental: LY3484356 Dose Level 1
    Administered orally.
    Intervention: Drug: LY3484356
  • Experimental: LY3484356 Dose Level 2
    Administered orally.
    Intervention: Drug: LY3484356
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 21, 2022
Estimated Primary Completion Date March 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04647487
Other Study ID Numbers  ICMJE 17575
J2J-MC-JZLB ( Other Identifier: Eli Lilly and Company )
2020-002810-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date April 1, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP