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History of Changes for Study: NCT04647487
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)
Latest version (submitted November 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 30, 2020 None (earliest Version on record)
2 December 2, 2020 Contacts/Locations, Study Status and References
3 December 17, 2020 Study Status and Contacts/Locations
4 January 6, 2021 Study Status
5 January 18, 2021 Study Status
6 February 3, 2021 Study Status and Contacts/Locations
7 February 18, 2021 Contacts/Locations and Study Status
8 March 2, 2021 Study Status
9 March 19, 2021 Study Status and Contacts/Locations
10 April 6, 2021 Contacts/Locations and Study Status
11 April 16, 2021 Study Status
12 May 4, 2021 Study Status and Contacts/Locations
13 May 17, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
14 June 8, 2021 Contacts/Locations and Study Status
15 July 6, 2021 Contacts/Locations and Study Status
16 July 15, 2021 Contacts/Locations and Study Status
17 September 2, 2021 Study Status and Contacts/Locations
18 October 4, 2021 Study Status and Contacts/Locations
19 October 19, 2021 Arms and Interventions and Study Status
20 November 17, 2021 Contacts/Locations and Study Status
21 December 6, 2021 Contacts/Locations, Study Status and Eligibility
22 December 16, 2021 Contacts/Locations and Study Status
23 January 17, 2022 Study Status and Contacts/Locations
24 March 2, 2022 Contacts/Locations, Arms and Interventions, Study Status, Eligibility and Study Design
25 April 6, 2022 Study Status and Contacts/Locations
26 June 8, 2022 Study Status and Contacts/Locations
27 June 21, 2022 Contacts/Locations and Study Status
28 July 7, 2022 Contacts/Locations and Study Status
29 July 18, 2022 Contacts/Locations and Study Status
30 August 17, 2022 Contacts/Locations and Study Status
31 November 23, 2022 Recruitment Status, Study Status and Contacts/Locations
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Study NCT04647487
Submitted Date:  November 30, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 17575
Brief Title: A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)
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
Secondary IDs: J2J-MC-JZLB [Eli Lilly and Company]
2020-002810-42 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 15, 2020
Overall Status: Not yet recruiting
Study Start: December 4, 2020
Primary Completion: March 21, 2022 [Anticipated]
Study Completion: March 21, 2022 [Anticipated]
First Submitted: November 30, 2020
First Submitted that
Met QC Criteria:
November 30, 2020
First Posted: December 1, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 30, 2020
Last Update Posted: December 1, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords: SERD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: LY3484356 Dose Level 1
Administered orally.
Drug: LY3484356
Administered orally.
Experimental: LY3484356 Dose Level 2
Administered orally.
Drug: LY3484356
Administered orally.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based: Yes
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Telephone: 1-317-615-4559
Email: ClinicalTrials.gov@lilly.com
Study Officials: 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)
Study Director
Eli Lilly and Company
Locations: United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Contact:Contact: 310-967-2700
Contact:Principal Investigator: Heather L McArthur
United States, Georgia
Winship Cancer Center Emory University
Atlanta, Georgia, United States, 30322
Contact:Contact: 4047781900
Contact:Principal Investigator: Manali Ajay Bhave
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Contact:Contact: 617-643-2208
Contact:Principal Investigator: Aditya Bardia
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact:Contact: 314-747-0063
Contact:Principal Investigator: Rebecca Aft
United States, Tennessee
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Contact:Principal Investigator: SMO Sarah Cannon Research Inst.
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Contact:Contact: 615-329-7274
Contact:Principal Investigator: Erika P Hamilton
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact:Contact: 713-798-2901
Contact:Principal Investigator: Alastair Thompson
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact:Contact: 713-792-7216
Contact:Principal Investigator: Kelly Hunt
United States, Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, United States, 53792-4108
Contact:Contact: 608-265-9701
Contact:Principal Investigator: Ruth O'Regan
Belgium
Institut Jules Bordet
Brussel, Belgium, 1000
Contact:Contact: 003225413189
Contact:Principal Investigator: Philippe Aftimos
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Contact:Contact: 003216344634
Contact:Principal Investigator: Patrick Neven
France
Centre Rene Huguenin - Institut Curie
Saint Cloud, France, 92210
Contact:Contact: 0033147111515
Contact:Principal Investigator: François Clément Bidard
Germany, Bayern
Universitätsklinikum Erlangen
Erlangen, Bayern, Germany, 91054
Contact:Contact: 004991318533553
Contact:Principal Investigator: Peter Fasching
Klinikum der Universität München
München, Bayern, Germany, 80337
Contact:Contact: 00498951604317
Contact:Principal Investigator: Nadia Harbeck
Germany, Schleswig-Holstein
Helios Kliniken Schwerin
Schwerin, Schleswig-Holstein, Germany, 13049
Contact:Contact: 00493855202300
Contact:Principal Investigator: Nicole Stahl
Spain
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Contact:Contact: 0034932275402
Contact:Principal Investigator: María Jesús Vidal Losada
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Contact:Contact: 0034915868115
Contact:Principal Investigator: Miguel Martin Jimenez
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Contact:Contact: 0034917567984
Contact:Principal Investigator: Eva Ciruelos Gil
United Kingdom, Cornwall
The Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact:Contact: 00441872258304
Contact:Principal Investigator: Duncan Angus Wheatley
United Kingdom, London City
Barts Cancer Institute
London, London City, United Kingdom, EC1A 7BE
Contact:Contact: 00442078823442
Contact:Principal Investigator: Peter Schmidt
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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