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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLB | Other Identifier | Eli Lilly and Company | |
| 2020-002810-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 milligrams (mg) LY3484356 | Experimental | Participants received 200 mg LY3484356 administered orally once daily for 15 days |
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| 400 mg LY3484356 | Experimental | Participants received 400 mg LY3484356 administered orally once daily for 15 days |
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| 800 mg LY3484356 | Experimental | Participants received 800 mg LY3484356 administered orally once daily for 15 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3484356 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Center Emory University | Atlanta | Georgia | 30322 | United States | ||
| Northwestern Memorial Hosptial |
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| Label | URL |
|---|---|
| A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (EMBER-2) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 mg LY3484356 | Participants received 200 mg LY3484356 administered orally once daily for 15 days |
| FG001 | 400 mg LY3484356 | Participants received 400 mg LY3484356 administered orally once daily for 15 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2022 | Oct 22, 2025 |
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| 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). | Baseline, Day 15 |
| Pharmacokinetics (PK): Plasma Concentration of LY3484356 | Plasma Concentration of LY3484356 evaluated using sparse sampling methodology | Day 1: 3.5 hours (h) postdose; Day 8: Predose; Day 8: 3.5 h postdose |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | 37203 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Institut Jules Bordet | Brussel - Capital | 1070 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Hôpital René Huguenin | Saint-Cloud | Hauts-de-Seine | 92210 | France |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Helios Kliniken Schwerin | Schwerin | Mecklenburg-Vorpommern | 19049 | Germany |
| Klinikum der Universitaet Muenchen | München | 80336 | Germany |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Madrid Norte Sanchinarro | Madrid | 28050 | Spain |
| The Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Barts Cancer Institute | London | London City | EC1A 7BE | United Kingdom |
| FG002 | 800 mg LY3484356 | Participants received 800 mg LY3484356 administered orally once daily for 15 days |
| Received At Least One Dose of Study Drug |
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| COMPLETED | Participants who have completed all on-treatment visits were considered completers. |
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| NOT COMPLETED |
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All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg LY3484356 | Participants received 200 mg LY3484356 administered orally once daily for 15 days |
| BG001 | 400 mg LY3484356 | Participants received 400 mg LY3484356 administered orally once daily for 15 days |
| BG002 | 800 mg LY3484356 | Participants received 800 mg LY3484356 administered orally once daily for 15 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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. | All enrolled participants with analyzable baseline and posttreatment data. | Mean | Standard Deviation | H-score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All enrolled participants with analyzable baseline and posttreatment data. | Posted | Geometric Mean | 90% Confidence Interval | percent change | Baseline, Day 15 |
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| Secondary | 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). | All enrolled participants with analyzable baseline and posttreatment data. | Posted | Geometric Mean | 90% Confidence Interval | percent change | Baseline, Day 15 |
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| Secondary | 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). | All enrolled participants with analyzable baseline and posttreatment data. | Posted | Geometric Mean | 90% Confidence Interval | percent change | Baseline, Day 15 |
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| Secondary | Pharmacokinetics (PK): Plasma Concentration of LY3484356 | Plasma Concentration of LY3484356 evaluated using sparse sampling methodology | All enrolled participants who received at least one full dose of study drug and have at least one postbaseline evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 1: 3.5 hours (h) postdose; Day 8: Predose; Day 8: 3.5 h postdose |
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Baseline until end of follow-up (up to 63 days)
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 mg LY3484356 | Participants received 200 mg LY3484356 administered orally once daily for 15 days | 0 | 28 | 1 | 28 | 15 | 28 |
| EG001 | 400 mg LY3484356 | Participants received 400 mg LY3484356 administered orally once daily for 15 days | 0 | 30 | 2 | 30 | 12 | 30 |
| EG002 | 800 mg LY3484356 | Participants received 800 mg LY3484356 administered orally once daily for 15 days | 0 | 28 | 1 | 28 | 15 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2020 | Oct 22, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
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| Belgium |
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| Germany |
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| United States |
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| France |
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| United Kingdom |
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| Units | Counts |
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| Participants |
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Participants received 800 mg LY3484356 administered orally once daily for 15 days
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