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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3484356
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring SERD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Winship Cancer Center Emory University
  • Northwestern Memorial Hosptial
  • Massachusetts General Hospital
  • Washington University School of Medicine
  • Sarah Cannon Research Institute SCRI
  • Baylor College of Medicine
  • University of Texas MD Anderson Cancer Center
  • University of Vermont Medical Center
  • Institut Jules Bordet
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Hôpital René Huguenin
  • Universitätsklinikum Erlangen
  • Helios Kliniken Schwerin
  • Klinikum der Universitaet Muenchen
  • Hospital Clinic I Provincial
  • Hospital General Universitario Gregorio Marañon
  • Hospital Madrid Norte Sanchinarro
  • The Royal Cornwall Hospital
  • Barts Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LY3484356 Dose Level 1

LY3484356 Dose Level 2

LY3484356 Dose Level 3

Arm Description

Administered orally.

Administered orally.

Administered orally.

Outcomes

Primary Outcome Measures

Change from Baseline in ER Expression
ER expression measured by H-score immunohistochemistry (IHC)

Secondary Outcome Measures

Change from Baseline in Ki-67 Index
Ki-67 index measured by percentage positive scoring by IHC
Change from Baseline in Progesterone Receptor (PR) Expression
PR expression measured by H-score IHC
PK: Plasma Concentration of LY3484356

Full Information

First Posted
November 30, 2020
Last Updated
March 29, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04647487
Brief Title
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
SERD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3484356 Dose Level 1
Arm Type
Experimental
Arm Description
Administered orally.
Arm Title
LY3484356 Dose Level 2
Arm Type
Experimental
Arm Description
Administered orally.
Arm Title
LY3484356 Dose Level 3
Arm Type
Experimental
Arm Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
LY3484356
Other Intervention Name(s)
Imlunestrant
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Change from Baseline in ER Expression
Description
ER expression measured by H-score immunohistochemistry (IHC)
Time Frame
Baseline, Day 15
Secondary Outcome Measure Information:
Title
Change from Baseline in Ki-67 Index
Description
Ki-67 index measured by percentage positive scoring by IHC
Time Frame
Baseline, Day 15
Title
Change from Baseline in Progesterone Receptor (PR) Expression
Description
PR expression measured by H-score IHC
Time Frame
Baseline, Day 15
Title
PK: Plasma Concentration of LY3484356
Time Frame
Baseline through follow-up at Day 15

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Winship Cancer Center Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Memorial Hosptial
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Institut Jules Bordet
City
Brussel - Capital
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hôpital René Huguenin
City
Saint-Cloud
State/Province
Hauts-de-Seine
ZIP/Postal Code
92210
Country
France
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Helios Kliniken Schwerin
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19049
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
The Royal Cornwall Hospital
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Barts Cancer Institute
City
London
State/Province
London City
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3vEdhySNhh4bT91vRoma1P
Description
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)

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

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