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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-OX-JZLC | Other Identifier | Eli Lilly and Company | |
| 2021-000079-35 | EudraCT Number | ||
| 2023-506786-63-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Imlunestrant | Experimental | Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. |
|
| Arm B: Investigator's Choice of Endocrine Therapy | Experimental | Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. |
|
| Arm C: Imlunestrant + Abemaciclib | Experimental | Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlunestrant | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
| Investigator-assessed PFS (Between Arm C and Arm A) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | Randomization to the date of first documented progression of disease or death from any cause (up to 26 months) |
| Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). |
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). |
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Inclusion Criteria:
Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
Must be deemed appropriate for treatment with endocrine therapy
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
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 |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39660834 | Derived | Jhaveri KL, Neven P, Casalnuovo ML, Kim SB, Tokunaga E, Aftimos P, Saura C, O'Shaughnessy J, Harbeck N, Carey LA, Curigliano G, Llombart-Cussac A, Lim E, Garcia Tinoco ML, Sohn J, Mattar A, Zhang Q, Huang CS, Hung CC, Martinez Rodriguez JL, Ruiz Borrego M, Nakamura R, Pradhan KR, Cramer von Laue C, Barrett E, Cao S, Wang XA, Smyth LM, Bidard FC; EMBER-3 Study Group. Imlunestrant with or without Abemaciclib in Advanced Breast Cancer. N Engl J Med. 2025 Mar 27;392(12):1189-1202. doi: 10.1056/NEJMoa2410858. Epub 2024 Dec 11. |
| Label | URL |
|---|---|
| Study of LY3484356 Versus Hormone Therapy, in Participants With Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer (EMBER-3) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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The study was initially planned with participants randomized 1:1 to either arm A or arm B. Following a protocol amendment, arm C was added later, after randomization to arms A and B had already begun.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Imlunestrant | Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. |
| FG001 | Arm B: Investigator's Choice of Endocrine Therapy |
| 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 | Jul 31, 2023 | May 7, 2025 |
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| Exemestane | Drug | Administered orally. |
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| Fulvestrant | Drug | Administered IM. |
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| Abemaciclib | Drug | Administered orally. |
|
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| Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
| Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
| Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm C and Arm A) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | Randomization to the date of first documented progression of disease or death from any cause (up to 25 months) |
| Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm A and Arm B) | ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | Randomization until measured progressive disease (up to 28 months) |
| Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B) | DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months) |
| Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm A and Arm B) | CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Randomization until measured progressive disease (up to 28 months) |
| Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A) | ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | Randomization until measured progressive disease (up to 26 months) |
| Investigator-assessed Duration of Response (DoR) (Between Arm C and Arm A) | DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months) |
| Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm C and Arm A) | CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Randomization until measured progressive disease (up to 26 months) |
| Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm A and Arm B) | Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment. | Randomization through follow-up (up to 24 months) |
| Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A) | Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment. | Randomization through follow-up (up to 20 months) |
| Pharmacokinetics (PK): Plasma Concentration of Imlunestrant |
| Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose) |
| Pharmacokinetics (PK): Plasma Concentration of Total Abemaciclib |
| Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose) |
| Overall Survival (OS) in the ITT Population | OS in the ITT population | Randomization until death from any cause (estimated as up to 5 years) |
| OS in the ESR1-mutation Detected Population | OS in the ESR1-mutation detected population | Randomization until death from any cause (estimated as up to 5 years) |
| Blinded Independent Review Committee (BIRC) Assessed PFS in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
| Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | Randomization until measured progressive disease (up to 28 months) |
| Investigator-assessed Duration of Response (DoR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months) |
| Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Randomization until measured progressive disease (up to 28 months) |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Marin Cancer Care | Greenbrae | California | 94904 | United States |
| University of California Davis (UC Davis) Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Banner MD Anderson Cancer Center at McKee Medical Center | Loveland | Colorado | 80538 | United States |
| Clermont Oncology Center | Clermont | Florida | 34711 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | 96819 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| NorthShore University HealthSystem - Evanston Hospital | Evanston | Illinois | 60201 | United States |
| IU Health Ball Memorial Hospital, Inc. | Muncie | Indiana | 47303 | United States |
| The University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | United States |
| Care Access - Clifton | Clifton | New Jersey | 07013 | United States |
| Memorial Sloan Kettering - Bergen | Montvale | New Jersey | 07645 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27599 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Mercy Health - St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Avera Cancer Institute Sioux Falls | Sioux Falls | South Dakota | 57105 | United States |
| Florida Cancer Specialists | Nashville | Tennessee | 37203 | United States |
| The Mark H Zangmeister Cancer Center | Nashville | Tennessee | 37203 | United States |
| USO - Texas Oncology - Allen | Allen | Texas | 75013 | United States |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | United States |
| Willamette Valley Cancer Institute & Research Ctr. | Houston | Texas | 77070 | United States |
| Texas Oncology - Carrollton | Lewisville | Texas | 75056 | United States |
| Texas Oncology - Denison | The Woodlands | Texas | 75020 | United States |
| Texas Oncology - Paris | The Woodlands | Texas | 75460 | United States |
| Blue Ridge Cancer Care | The Woodlands | Texas | 77380 | United States |
| Broome Oncology | The Woodlands | Texas | 77380 | United States |
| Minnesota Oncology/Hematology PA | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Carrollton | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - McKinney | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Medical City Dallas | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Methodist Charlton Cancer Center | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - San Antonio Medical Center | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - The Woodlands | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Willowbrook | The Woodlands | Texas | 77380 | United States |
| Texas Oncology Fort Worth | The Woodlands | Texas | 77380 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | The Woodlands | Texas | 77380 | United States |
| USO-Rocky Mountain Cancer Center | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Austin Central | The Woodlands | Texas | 78731 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| The University of Vermont Medical Center Inc. | Burlington | Vermont | 05401 | United States |
| Instituto de Investigaciones Clínicas Mar del Plata | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| CIPREC | Buenos Aires | Buenos Aires F.D. | C1061AAS | Argentina |
| Fundación Cenit Para La Investigación En Neurociencias | CABA | Buenos Aires F.D. | 1125 | Argentina |
| Centro Medico Privado CEMAIC | Capital | Córdoba Province | X5008HHW | Argentina |
| Clinica Viedma | Viedma | Río Negro Province | 8500 | Argentina |
| Instituto Argentino de Diagnóstico y Tratamiento (IADT) | Buenos Aires | 1122 | Argentina |
| Instituto San Marcos | San Juan | 5400 | Argentina |
| Sanatorio Norte | Santiago del Estero | 4200 | Argentina |
| St Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Ashford Cancer Centre Research | Kurralta Park | South Australia | 5037 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Maroondah Hospital | Melbourne | Victoria | 3135 | Australia |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | State of Vienna | 1090 | Austria |
| Medizinische Universität Graz | Graz | Styria | 8036 | Austria |
| Uniklinikum Salzburg | Salzburg | 5020 | Austria |
| Imelda General Hospital | Bonheiden | Antwerpen | 2820 | Belgium |
| Institut Jules Bordet | Brussels | Bruxelles-Capitale, Région de | 1000 | Belgium |
| UZ Brussel | Brussels | Bruxelles-Capitale, Région de | 1090 | Belgium |
| UZ Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| AZ Nikolaas | Sint-Niklaas | Oost-Vlaanderen | B-9100 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| AZ Groeninge Campus Kennedylaan | Kortrijk | West-Vlaanderen | 8500 | Belgium |
| CHU UCL Namur/Site Sainte Elisabeth | Namur | 5000 | Belgium |
| Hospital de Cancer de Londrina | Londrina | Paraná | 86015-520 | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-650 | Brazil |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | 01246-000 | Brazil |
| Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA | São Paulo | 01317-001 | Brazil |
| Núcleo de Pesquisa Clínica da Rede São Camilo | São Paulo | 04014-002 | Brazil |
| Afflilated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
| Beijing Hospital | Beijing | Beijing Municipality | 100005 | China |
| Fifth Medical Center of PLA General Hospital | Beijing | Beijing Municipality | 100039 | China |
| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Sun Yat-Sen University Cancer Centre | Guangzhou | Guangdong | 511400 | China |
| Jiangmen Center Hospital | Jiangmen | Guangdong | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 518035 | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524001 | China |
| Zhongshan Peoples Hospital | Zhongshan | Guangdong | 528403 | China |
| The Fifth Affiliated Hospital of Sun Yat-Sen University | Zhuhai | Guangdong | 519000 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang | Henan | 471003 | China |
| Nanyang Second General Hospital | Nanyang | Henan | 473000 | China |
| Tongji Hospital Tongji Medical,Science & Technology | Wuhan | Hubei | 430030 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| The First People's Hospital of Changde City | Changde | Hunan | 415003 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 421000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The Third Hospital of Nanchang | Nanchang | Jiangxi | 330009 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Sichuan Cancer hospital | Chengdu | Sichuan | 610042 | China |
| The Second People's Hospital of Neijiang | Neijiang | Sichuan | 641000 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Hwa Mei Hospital University of Chinese Academy of Sciences | Ningbo | Zhejiang | 315010 | China |
| Ningbo Medical Center | Ningbo | Zhejiang | 315048 | China |
| Nemocnice Horovice | Hořovice | Beroun | 268 31 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Praha 10 | 10034 | Czechia |
| Fakultni Thomayerova nemocnice | Prague | Praha 4 | 14059 | Czechia |
| Nemocnice Na Bulovce | Prague | Praha 8 | 180 81 | Czechia |
| Oblastni nemocnice Pribram | Příbram | Příbram | 261 01 | Czechia |
| Institut de cancérologie Strasbourg Europe (ICANS) | Strasbourg | Alsace | 67033 | France |
| Polyclinique De Blois | La Chaussée-Saint-Victor | Centre-Val de Loire | 41260 | France |
| CHU Besançon | Besançon | Doubs | 25000 | France |
| Hôpital René Huguenin | Saint-Cloud | Hauts-de-Seine | 92210 | France |
| Centre de Cancérologie du Grand Montpellier | Montpellier | Languedoc-Roussillon | 34070 | France |
| Clinique Victor Hugo Le Mans | Le Mans | Pays de la Loire Region | 72000 | France |
| Centre Hospitalier de la Côte Basque | Bayonne | Pyrénées-Atlantiques | 64109 | France |
| Institut Curie | Paris | 75248 | France |
| Institut de Cancérologie de Lorraine Alexis Vautrin | Vandœuvre-lès-Nancy | 54519 | France |
| Klinikum Ludwigsburg | Ludwigsburg | Baden-Wurttemberg | 71640 | Germany |
| Onkologiezentrum Donauwörth | Donauwörth | Bavaria | 86609 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen | München | Bavaria | 80336 | Germany |
| Agaplesion Markus Krankenhaus | Frankfurt am Main | Hesse | 60431 | Germany |
| Gynäkologisch-Onkologische Praxis am Pelikanplatz | Hanover | Lower Saxony | 30177 | Germany |
| Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung | Essen | North Rhine-Westphalia | 45136 | Germany |
| Evangelisches Krankenhaus Bethesda Mönchengladbach | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Agios Savvas Regional Cancer Hospital | Athens | Attikí | 115 22 | Greece |
| Alexandra Hospital | Athens | Attikí | 115 28 | Greece |
| General Oncology Hospital of Kifissia "Agioi Anargiroi" | Nea Kifissia | Attikí | 14564 | Greece |
| University General Hospital of Heraklion | Heraklion | Irakleío | 711 10 | Greece |
| Euromedica General Clinic of Thessaloniki | Thessaloniki | Thessaloníki | 546 45 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | Thessaloníki | 564 29 | Greece |
| European Interbalkan Medical Center | Thessaloniki | Thessaloníki | 570 01 | Greece |
| University General Hospital of Larissa | Larissa | Thessalía | 41110 | Greece |
| Medstar Speciality Hospital | Bangalore | Karnataka | 560092 | India |
| Regional Cancer Centre - Thiruvananthapuram | Thiruvananthapuram | Kerala | 695011 | India |
| HCG Cancer Centre | Mumbai | Maharashtra | 400092 | India |
| Government Medical College And Hospital - Nagpur | Nagpur | Maharashtra | 440003 | India |
| Rashtrasant Tukdoji Regional Cancer Hospital | Nagpur | Maharashtra | 440027 | India |
| HCG Manavata Cancer Centre | Nashik | Maharashtra | 422002 | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411004 | India |
| Lifepoint Multispeciality Hospital | Pune | Maharashtra | 411057 | India |
| Yashoda Hospitals | Hyderabad | Telangana | 500082 | India |
| University of Naples Federico II | Naples | Campania | 80100 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale | Naples | Campania | 80131 | Italy |
| Cro-Irccs | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Ospedale San Martino | Genoa | Liguria | 16132 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50134 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| Chiba cancer center | Chiba | Chiba | 260-8717 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Kurume General Hospital | Kurume | Fukuoka | 830-0013 | Japan |
| Gunma Prefectural Cancer Center | Otashi | Gunma | 373-8550 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| Shinko Hospital | Kobe | Hyōgo | 651-0072 | Japan |
| Tsuchiura Kyodo General Hospital | Tsuchiura | Ibaraki | 300-0028 | Japan |
| Tsukuba University Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| St. Marianna University School of Medicine Hospital | Kawasaki | Kanagawa | 216-8511 | Japan |
| Kanagawa cancer center | Yokohama | Kanagawa | 2418515 | Japan |
| Nagano Municipal Hospital | Tomitake | Nagano | 381-8551 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| Showa University Hospital | Shinagawa | Tokyo | 142-8555 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Hiroshima City Hospital | Hiroshima | 730-8518 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Kumamoto Shinto General Hospital | Kumamoto | 862-8655 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Shizuoka General Hospital | Shizuoka | 420-8527 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Centro de Investigación Clínica de Alta Especialidad | Torreón | Coahuila | 27010 | Mexico |
| COI Centro Oncologico Internacional S.A.P.I. de C.V. | Álvaro Obregón | Mexico City | 01330 | Mexico |
| Grupo Medico Camino Sc | Mexico City | Mexico City | 03310 | Mexico |
| Private Practice - Dr. Joaquin Reinoso | Monterrey | Nuevo León | 64320 | Mexico |
| Filios Alta Medicina | Monterrey | Nuevo León | 64460 | Mexico |
| Centro Medico Zambrano Hellion | San Pedro Garza García | Nuevo León | 66278 | Mexico |
| Unidad de Investigación en Salud | Chihuahua City | 31203 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Unidad Médica Onco-hematológica | Puebla City | 72424 | Mexico |
| Maastricht UMC+ | Maastricht | Limburg | 6229 HX | Netherlands |
| Medische Centrum Leeuwarden | Leeuwarden | Provincie Friesland | 8934 AD | Netherlands |
| Haga Ziekenhuis locatie Leyweg | The Hague | South Holland | 2545 AA | Netherlands |
| Kaluga Regional Clinical Oncology Center | Kaluga | Kalužskaja Oblast' | 248007 | Russia |
| Volgograd Regional Clinical Cancer Clinic No.1 | Volgograd | Volgograd Oblast | 400138 | Russia |
| N.N.Petrov Research Institute of Oncology | Saint Petersburg | 197758 | Russia |
| Soon Chun Hyang University Cheonan Hospital | Cheonan-si | Chungcheongnam-do [Chungnam] | 31151 | South Korea |
| Gachon University Gil Medical Center | Namdong-gu | Incheon-gwangyeoksi [Incheon] | 21565 | South Korea |
| Ajou University Hospital | Suwon | Kyǒnggi-do | 16499 | South Korea |
| Yeungnam Univeristy Medical Center | Daegu | Kyǒngsangbuk-do | 42415 | South Korea |
| Dong-A University Hospital | Busan | Pusan-Kwangyǒkshi | 49201 | South Korea |
| Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [Seoul] | 03722 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 06273 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | Taegu-Kwangyǒkshi | 41404 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Universitari Dexeusa | Barcelona | Catalunya [Cataluña] | 08028 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [Cataluña] | 08041 | Spain |
| Hospital San Pedro de Alcántara | Cáceres | Extremadura | 10003 | Spain |
| Hospital Universitario Arnau de Vilanova de Lleida | Lleida | Lleida [Lérida] | 25198 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Hospital Clinico de Valencia | Valencia | Valenciana, Comunitat | 46010 | Spain |
| Hospital Quirónsalud Valencia | Valencia | València | 46010 | Spain |
| Hospital Universitario San Cecilio | Granada | 18016 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Chi Mei Hospital - Liouying Branch | Tainan | Tainan | 73657 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Medipol University Medical Faculty | Stanbul | Istanbul | 34214 | Turkey (Türkiye) |
| Acibadem Altunizade Hospital | Üsküdar / Stanbul | Istanbul | Turkey (Türkiye) |
| Baskent University Dr. Turgut Noyan Research and Training Center | Adana | 01250 | Turkey (Türkiye) |
| University of Health Sciences,Gulhane School of Medicine | Ankara | 06010 | Turkey (Türkiye) |
| Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital | Ankara | 06200 | Turkey (Türkiye) |
| Hacettepe Universitesi | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi | Ankara | 06520 | Turkey (Türkiye) |
| Ankara Bilkent Şehir Hastanesi | Ankara | 06800 | Turkey (Türkiye) |
| Akdeniz Universitesi Hastanesi | Antalya | 07059 | Turkey (Türkiye) |
| Dicle Üniversitesi | Diyarbakır | 21200 | Turkey (Türkiye) |
| Trakya University | Edirne | 22030 | Turkey (Türkiye) |
| Acıbadem Maslak Hastanesi | Istanbul | 34457 | Turkey (Türkiye) |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Ege Universitesi Hastanesi | Izmir | 35100 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi | Malatya | 44280 | Turkey (Türkiye) |
| Mersin University | Mersin | 33343 | Turkey (Türkiye) |
| Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council | Kryvyi Rih | Dnipropetrovsk Oblast | 50048 | Ukraine |
| CNPE "Regional Center of Oncology" | Kharkiv | Kharkiv Oblast | 61070 | Ukraine |
| Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council | Odesa | Odesa Oblast | 65025 | Ukraine |
| Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council | Lutsk | Volyn Oblast | 43018 | Ukraine |
| Uzhgorod Central City Clinical Hospital | Uzhhorod | Zakarpattia Oblast | 88000 | Ukraine |
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. |
| FG002 | Arm C: Imlunestrant + Abemaciclib | Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met. |
| Analysis Population for the Comparison Between Arm A and Arm B | All participants who were randomly assigned to either Arm A or Arm B. |
|
| Analysis Population for the Comparison Between Arm C and Arm A | For analyses between arm C and arm A, the study was planned to include participants who were randomized to these arms concurrently. |
|
| Estrogen Receptor 1 (ESR1) Mutation-Detected Population for Comparison Between Arm A and Arm B |
|
| Received at Least 1 Dose of Study Drug |
|
| Safety Analysis Population | All randomised participants who received at least 1 dose of study drug. Participants were analyzed according to the study treatment they actually received. |
|
| COMPLETED | Participants with progressive disease or death were considered study completers. |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Imlunestrant | Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. |
| BG001 | Investigator's Choice of Endocrine Therapy | Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. |
| BG002 | Imlunestrant + Abemaciclib | Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Estrogen Receptor 1 (ESR1)-Mutation | Count of Participants | Participants | No |
|
| 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 | Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm B (including censored). Number of participants censored in "Arm A=94," "Arm B=77." | Posted | Median | 95% Confidence Interval | Months | Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
|
|
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| Primary | Investigator-assessed PFS (Between Arm C and Arm A) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm C concurrently (including censored). Number of participants censored in "Arm C=99," "Arm A=64." | Posted | Median | 95% Confidence Interval | Months | Randomization to the date of first documented progression of disease or death from any cause (up to 26 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm B and had ESR1 mutations detected at baseline (including censored). Number of participants censored in "Arm A=29," "Arm B=16." | Posted | Median | 95% Confidence Interval | Months | Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
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| Secondary | Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm B (including censored). Number of participants censored in "Arm A=171," "Arm B=171." | Posted | Median | 95% Confidence Interval | Months | Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
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| Secondary | Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm C and Arm A) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm C concurrently (including censored). Number of participants censored in "Arm C=132," "Arm A=116." | Posted | Median | 95% Confidence Interval | Months | Randomization to the date of first documented progression of disease or death from any cause (up to 25 months) |
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| Secondary | Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm A and Arm B) | ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | All participants who were randomly assigned to either arm A or arm B. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until measured progressive disease (up to 28 months) |
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| Secondary | Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B) | DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm B and had achieved CR or PR responses (including censored). Number of participants censored in "Arm A=17," "Arm B=7." | Posted | Median | 95% Confidence Interval | Months | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months) |
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| Secondary | Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm A and Arm B) | CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who were randomly assigned to either arm A or arm B. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until measured progressive disease (up to 28 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A) | ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | All participants who were randomly assigned to either arm A or arm C concurrently. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until measured progressive disease (up to 26 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator-assessed Duration of Response (DoR) (Between Arm C and Arm A) | DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm C or arm A and had achieved CR or PR responses (including censored). Number of participants censored in "Arm C=30," "Arm A=11." | Posted | Median | 95% Confidence Interval | Months | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months) |
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| Secondary | Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm C and Arm A) | CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who were randomly assigned to either arm A or arm C concurrently. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until measured progressive disease (up to 26 months) |
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| Secondary | Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm A and Arm B) | Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment. | All participants who were randomly assigned to either arm A or arm B and had at least one NRS assessment available (including censored). Number of participants censored in "Arm A=258," "Arm B=267." | Posted | Median | 95% Confidence Interval | Months | Randomization through follow-up (up to 24 months) |
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| Secondary | Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A) | Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (≥2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment. | All participants who were randomly assigned to either arm A or arm C concurrently and had at least one NRS assessment available (including censored). Number of participants censored in "Arm C=163," "Arm A=162." | Posted | Median | 95% Confidence Interval | Months | Randomization through follow-up (up to 20 months) |
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| Secondary | Pharmacokinetics (PK): Plasma Concentration of Imlunestrant |
| All randomised participants who received at least 1 dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose) |
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| Secondary | Pharmacokinetics (PK): Plasma Concentration of Total Abemaciclib |
| All randomised participants who received at least 1 dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the ITT Population | OS in the ITT population | Not Posted | May 2028 | Randomization until death from any cause (estimated as up to 5 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS in the ESR1-mutation Detected Population | OS in the ESR1-mutation detected population | Not Posted | May 2028 | Randomization until death from any cause (estimated as up to 5 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Blinded Independent Review Committee (BIRC) Assessed PFS in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm B and had ESR1 mutations detected at baseline (including censored). Number of participants censored in "Arm A=64," "Arm B=47." | Posted | Median | 95% Confidence Interval | Months | Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | All participants who were randomly assigned to either arm A or arm B and had ESR1 mutations detected at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until measured progressive disease (up to 28 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Investigator-assessed Duration of Response (DoR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). | All participants who were randomly assigned to either arm A or arm B, had ESR1 mutations detected at baseline and had achieved CR or PR responses (including censored). Number of participants censored in "Arm A=5," "Arm B=0." | Posted | Median | 95% Confidence Interval | Months | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B) | CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (≥) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who were randomly assigned to either arm A or arm B and had ESR1 mutations detected at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization until measured progressive disease (up to 28 months) |
|
Baseline up to 28 months
Adverse events were reported for the "Safety Analysis Population."
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Imlunestrant | Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. | 62 | 327 | 46 | 327 | 250 | 327 |
| EG001 | Arm B: Investigator's Choice of Endocrine Therapy - Exemestane | This group includes Arm B participants for whom the Investigator's Choice of Endocrine Therapy was Exemestane. Participants received exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle until disease progression or a criterion for discontinuation was met. | 8 | 32 | 6 | 32 | 26 | 32 |
| EG002 | Arm B: Investigator's Choice of Endocrine Therapy - Fulvestrant | This group includes Arm B participants for whom the Investigator's Choice of Endocrine Therapy was Fulvestrant. Participants received Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. | 82 | 292 | 49 | 292 | 229 | 292 |
| EG003 | Arm C: Imlunestrant + Abemaciclib | Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met. | 36 | 208 | 42 | 208 | 203 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctival papillae | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Campylobacter colitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes simplex encephalitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Ureteric injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Panic reaction | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Wound treatment | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
| 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 | Aug 24, 2023 | May 7, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
| C056516 | exemestane |
| D000077267 | Fulvestrant |
| C000590451 | abemaciclib |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not detected |
|
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
|
|
|
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
|
|
|
|
|
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
|
|
|
|
|
|
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met. |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. |
|
|
|
|
|
|
Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met. |
|
|