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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLA | Other Identifier | Eli Lilly and Company | |
| 2019-003581-41 | EudraCT Number |
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The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation LY3484356 | Experimental | LY3484356 given orally. |
|
| Part A: Dose Expansion: LY3484356 + Abemaciclib +/- AI | Experimental | LY3484356 and abemaciclib given orally in combination with or without Aromatase Inhibitor (AI) of physician's choice (Anastrozole, Exemestane, or Letrozole) administered orally. |
|
| Part B: Dose Expansion: Cohort E3: LY3484356 | Experimental | LY3484356 given orally. |
|
| Part B: Dose Expansion: Cohort E4: LY3484356 + Everolimus | Experimental | LY3484356 and everolimus given orally. |
|
| Part B: Dose Expansion: Cohort E5: LY3484356 + Alpelisib | Experimental | LY3484356 and alpelisib given orally. |
|
| Part C:Dose Expansion: LY3484356 + Trastuzumab +/- Abemaciclib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3484356 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities | Number of Participants with DLTs and DLT-Equivalent Toxicities | Baseline through Cycle 1 (21/28 Day Cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356 | PK: AUC of LY3484356 | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) |
| PK: Maximum Concentration (Cmax) of LY3484356 |
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Inclusion Criteria:
All study parts:
Dose escalation- Participants must have one of the following:
Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer
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 |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic in Arizona - Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41423595 | Derived | Bhave M, Jhaveri KL, Kaufman PA, Aftimos P, Lombard J, Giridhar KV, Im SA, Ma CX, Lee KT, Kim SB, Sohn J, Li Y, Yuen E, Estrem ST, Nguyen B, Makena MR, Ismail-Khan R, Beeram M. Imlunestrant, an oral selective estrogen receptor degrader, in combination with HER2 directed therapy, with or without abemaciclib, in ER-positive, HER2-positive advanced breast cancer: results from the phase 1a/1b EMBER study. Breast Cancer Res. 2025 Dec 21;28(1):18. doi: 10.1186/s13058-025-02168-6. | |
| 39241211 |
| Label | URL |
|---|---|
| A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer | View source |
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| Experimental |
LY3484356 administered orally in combination with trastuzumab intravenously with or without Abemaciclib. |
|
| Part D: Dose Expansion: LY3484356 +/- Abemaciclib | Experimental | LY3484356 and Abemaciclib given orally with trastuzumab administered intravenously. |
|
| Part E: Dose Expansion: LY3484356 + Trastuzumab + Pertuzumab | Experimental | LY3484356 administered orally in combination with trastuzumab and pertuzumab administered intravenously. |
|
|
| Abemaciclib | Drug | Administered orally |
|
|
| Everolimus | Drug | Administered orally |
|
| Alpelisib | Drug | Administered orally |
|
| Trastuzumab | Drug | Administered intravenously |
|
| Aromatase Inhibitor (AI) | Drug | Anastrozole or Exemestane or Letrozole administered orally (physician choice) |
|
| Pertuzumab | Drug | Administered intravenously |
|
PK: Cmax of LY3484356
| Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) |
| PK: AUC of LY3484356 in Combination with Other Anticancer Therapies | PK: AUC of LY3484356 in Combination with Other Anticancer Therapies | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) |
| PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies | PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) |
| Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1 | Baseline through Disease Progression or Death (Estimated up to 28 Months) |
| Duration of Response (DoR): Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier | DoR: Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 28 Months) |
| Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response (BOR) of CR, PR, and Stable Disease (SD) as per RECIST v1.1 | DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1 | Baseline through Measured Progressive Disease (Estimated up to 28 Months) |
| Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1 | CBR: Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1 | Baseline through Measured Progressive Disease (Estimated up to 28 Months) |
| Progression Free Survival (PFS): Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier | PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 28 Months) |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| University of California, Irvine | Orange | California | 92868 | United States |
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| Lake Nona DDU | Orlando | Florida | 32827 | United States |
| Winship Cancer Center Emory University | Atlanta | Georgia | 30322 | United States |
| Community Cancer Center North | Indianapolis | Indiana | 46250 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering - Bergen | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Cancer Center | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Wilmot Cancer Institute | Rochester | New York | 14642 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health Sciences Center, Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504 | United States |
| UPMC Hillman Cancer Center Harrisburg | Harrisburg | Pennsylvania | 17109 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Vanderbilt Health One Hundred Oaks | Nashville | Tennessee | 37067 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology Nashville | Nashville | Tennessee | 37203 | United States |
| UT Southwestern Med Center | Dallas | Texas | 75390-9179 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 77380 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | 78229-3307 | United States |
| Minnesota Oncology/Hematology PA | The Woodlands | Texas | 77380 | United States |
| Oncology and Hematology Associates of Southwest Virginia Inc | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - San Antonio Medical Center | The Woodlands | Texas | 77380 | United States |
| US Oncology | The Woodlands | Texas | 77380 | United States |
| USO-Rocky Mountain Cancer Center | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
| The University of Vermont Medical Center Inc. | Burlington | Vermont | 05401 | United States |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Cancer Research SA | Adelaide | South Australia | 5000 | Australia |
| Breast Cancer Research Centre-WA | Nedlands | Western Australia | 6009 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Antwerp University Hospital | Edegem | Antwerpen | 2650 | Belgium |
| Institut Jules Bordet | Anderlecht | Bruxelles-Capitale, Région de | 1070 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Institut Curie | Paris | 75248 | France |
| Institut de cancérologie Strasbourg Europe (ICANS) | Strasbourg | 67033 | France |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Severance Hospital, Yonsei University Health System | Seoul | Korea | 03722 | South Korea |
| Seoul National University Hospital | Seoul | Seoul, Korea | 03080 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Clínic de Barcelona | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Valenciana, Comunitat | 46010 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Fundación Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Kaohsiung Medical University Hospital | Kaohsiung City | 80756 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Cheng-Kung Uni. Hosp. | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10055 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Derived |
| Jhaveri KL, Lim E, Jeselsohn R, Ma CX, Hamilton EP, Osborne C, Bhave M, Kaufman PA, Beck JT, Manso Sanchez L, Parajuli R, Wang HC, Tao JJ, Im SA, Harnden K, Yonemori K, Dhakal A, Neven P, Aftimos P, Pierga JY, Lu YS, Larson T, Jerez Y, Sideras K, Sohn J, Kim SB, Saura C, Bardia A, Sammons SL, Bacchion F, Li Y, Yuen E, Estrem ST, Rodrik-Outmezguine V, Nguyen B, Ismail-Khan R, Smyth L, Beeram M. Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and in Combination With Targeted Therapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Phase Ia/Ib EMBER Study. J Clin Oncol. 2024 Dec 10;42(35):4173-4186. doi: 10.1200/JCO.23.02733. Epub 2024 Sep 6. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
| C000590451 | abemaciclib |
| D000068338 | Everolimus |
| C585539 | Alpelisib |
| D000068878 | Trastuzumab |
| D047072 | Aromatase Inhibitors |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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