Breast CancerPhase 1EMBER-2NCT04647487
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
A Phase 1 study testing LY3484356 in people with Breast Cancer, run by Eli Lilly and Company at 19 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LY3484356
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 21 Apr 2021to 11 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
United States8 sites
Winship Cancer Center Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Vermont Medical Center
Burlington, Vermont, 05401
Northwestern Memorial Hosptial
Chicago, Illinois, 60611
Baylor College of Medicine
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
Washington University School of Medicine
St Louis, Missouri, 63110
Germany3 sites
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Klinikum der Universitaet Muenchen
München, 80336
Helios Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19049
Spain3 sites
Hospital Clinic I Provincial
Barcelona, 08036
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Madrid Norte Sanchinarro
Madrid, 28050
Belgium2 sites
Institut Jules Bordet
Brussel - Capital, 1070
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
United Kingdom2 sites
Barts Cancer Institute
London, London City, EC1A 7BE
The Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- LY3484356
- Keywords
- SERD
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3484356Drug
Also called Imlunestrant
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 200 milligrams (mg) LY3484356 | Experimental | Participants received 200 mg LY3484356 administered orally once daily for 15 days Receives: Drug: LY3484356 |
| 400 mg LY3484356 | Experimental | Participants received 400 mg LY3484356 administered orally once daily for 15 days Receives: Drug: LY3484356 |
| 800 mg LY3484356 | Experimental | Participants received 800 mg LY3484356 administered orally once daily for 15 days Receives: Drug: LY3484356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Estrogen Receptor (ER) Expression
Tumor tissue collected by biopsy is used to determine ER expression. ER expression is measured by immunohistochemistry (IHC) and quantified by H-score. The H-score was calculated as the sum of multiplying the tumor cell ER staining intensity level 0 to 3 (0=none, 1=low, 2=moderate, 3=high) by the percentage (0 to 100) of cells at each intensity. Total ER H-score ranged from 0 to 300, where a higher score indicated stronger ER expression. Percent change in ER expression was defined as 100*(ER expression on-treatment - ER expression pre-treatment)/(ER expression pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(ER expression on-treatment/ER expression pre-treatment).
Measured: Baseline, Day 15
Secondary outcomes (3)
Percent Change From Baseline in Ki-67
Tumor tissue collected by biopsy is used to determine Ki-67 expression. It is measured by IHC and the Ki-67 index is defined as the percent of cells staining positive by validated central assay. Percent change in Ki-67 index was defined as 100*(Ki-67 index on-treatment - Ki-67 index pre-treatment)/(Ki-67 index pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(Ki-67 index on-treatment/Ki-67 index pre-treatment).
Measured: Baseline, Day 15
Percent Change From Baseline in Progesterone Receptor (PR) Expression
Tumor tissue collected by biopsy is used to determine PR expression. PR expression is measured by IHC and quantified by H-score. The H-score was calculated as the sum of multiplying the tumor cell ER staining intensity level 0 to 3 (0=none, 1=low, 2=moderate, 3=high) by the percentage (0 to 100) of cells at each intensity. Total PR H-score ranged from 0 to 300, where a higher score indicated stronger PR expression. Percent change in PR expression was defined as 100*(PR expression on-treatment - PR expression pre-treatment)/(PR expression pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(PR expression on-treatment/PR expression pre-treatment).
Measured: Baseline, Day 15
Pharmacokinetics (PK): Plasma Concentration of LY3484356
Plasma Concentration of LY3484356 evaluated using sparse sampling methodology
Measured: Day 1: 3.5 hours (h) postdose; Day 8: Predose; Day 8: 3.5 h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start21 Apr 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647487
- Sponsor's protocol ID
- 17575
- Other IDs
- J2J-MC-JZLB, 2020-002810-42
- Acronym
- EMBER-2
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2020
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04647487
- Acronym / sponsor ID
- EMBER-2 / 17575
- Conditions
- Breast Cancer
- Keywords
- SERD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 milligrams (mg) LY3484356 | Experimental | Drug: LY3484356Participants received 200 mg LY3484356 administered orally once daily for 15 days |
| 400 mg LY3484356 | Experimental | Drug: LY3484356Participants received 400 mg LY3484356 administered orally once daily for 15 days |
| 800 mg LY3484356 | Experimental | Drug: LY3484356Participants received 800 mg LY3484356 administered orally once daily for 15 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3484356Also: ImlunestrantAdministered orally. | Drug | 200 milligrams (mg) LY3484356, 400 mg LY3484356, 800 mg LY3484356 |
Primary outcome
Percent Change From Baseline in Estrogen Receptor (ER) Expression
Time frame: Baseline, Day 15
Tumor tissue collected by biopsy is used to determine ER expression. ER expression is measured by immunohistochemistry (IHC) and quantified by H-score. The H-score was calculated as the sum of multiplying the tumor cell ER staining intensity level 0 to 3 (0=none, 1=low, 2=moderate, 3=high) by the percentage (0 to 100) of cells at each intensity. Total ER H-score ranged from 0 to 300, where a higher score indicated stronger ER expression. Percent change in ER expression was defined as 100*(ER expression on-treatment - ER expression pre-treatment)/(ER expression pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(ER expression on-treatment/ER expression pre-treatment).
3 secondary outcomes
Percent Change From Baseline in Ki-67
Time frame: Baseline, Day 15
Percent Change From Baseline in Progesterone Receptor (PR) Expression
Time frame: Baseline, Day 15
Pharmacokinetics (PK): Plasma Concentration of LY3484356
Time frame: Day 1: 3.5 hours (h) postdose; Day 8: Predose; Day 8: 3.5 h postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3484356 in people with Breast Cancer, run by Eli Lilly and Company at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Germany, Spain, Belgium, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Estrogen Receptor (ER) Expression (time frame: Baseline, Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.