Клинические исследование Breast Neoplasms: Imlunestrant, Exemestane, Fulvestrant, Abemaciclib

Спонсоры	Ведущий спонсор: Eli Lilly and Company
Источник	Eli Lilly and Company
Краткое содержание	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.

Общий статус

Recruiting

Дата начала

2021-10-04

Дата завершения

2026-09-13

Дата первичного завершения

2023-06-13

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Progression Free Survival (PFS)	Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)

Вторичный результат

Мера	Временное ограничение
Overall Survival (OS)	Randomization until death from any cause (estimated as up to 5 years)
Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)	Randomization until measured progressive disease (estimated as up to 1 year)
Duration of Response (DoR)	Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks	Randomization until measured progressive disease (estimated as up to 1 year)
PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma	Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
Progression Free Survival (PFS)	Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)
Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain"	Screening through follow-up (estimated as up to 3 years)
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant	Cycle 2 to Cycle 4 (cycle = 28 days)
PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib	Cycle 2 to Cycle 4 (cycle = 28 days)

Регистрация

800

Состояние	Breast Neoplasms Neoplasm Metastasis
Вмешательство	Тип вмешательства: Drug Название вмешательства: Imlunestrant Описание: Administered orally. Другое имя: LY3484356 Тип вмешательства: Drug Название вмешательства: Exemestane Описание: Administered orally. Этикетка Arm Group: Investigator's Choice of Endocrine Therapy Тип вмешательства: Drug Название вмешательства: Fulvestrant Описание: Administered IM. Этикетка Arm Group: Investigator's Choice of Endocrine Therapy Тип вмешательства: Drug Название вмешательства: Abemaciclib Описание: Administered orally. Этикетка Arm Group: Imlunestrant plus Abemaciclib Другое имя: LY2835219
Приемлемость	Критерии: 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: - Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor - Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease. - Have symptomatic or untreated brain metastasis. - Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study - Known allergic reaction against any of the components of the study treatment Пол: All Минимальный возраст: 18 Years Максимальный возраст: N/A Здоровые волонтеры: No

Состояние

Breast Neoplasms
Neoplasm Metastasis

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Imlunestrant

Описание: Administered orally.

Другое имя: LY3484356

Тип вмешательства: Drug

Название вмешательства: Exemestane

Описание: Administered orally.

Этикетка Arm Group: Investigator's Choice of Endocrine Therapy

Тип вмешательства: Drug

Название вмешательства: Fulvestrant

Описание: Administered IM.

Этикетка Arm Group: Investigator's Choice of Endocrine Therapy

Тип вмешательства: Drug

Название вмешательства: Abemaciclib

Описание: Administered orally.

Этикетка Arm Group: Imlunestrant plus Abemaciclib

Другое имя: LY2835219

Приемлемость

Критерии:

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: - Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor - Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease. - Have symptomatic or untreated brain metastasis. - Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study - Known allergic reaction against any of the components of the study treatment

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Study Director	Eli Lilly and Company

Общий контакт

Фамилия: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Телефон: 1-317-615-4559

Расположение

Объект:	Положение дел:	Контакт:	Исследователь:
Ironwood Cancer & Research Centers \| Chandler, Arizona, 85224, United States	Recruiting	480-314-6694	Mikhail I Shtivelband Principal Investigator
Banner MD Anderson Cancer Center \| Gilbert, Arizona, 85234, United States	Not yet recruiting	480-256-6444	Lida Mina Principal Investigator
Pacific Cancer Care \| Monterey, California, 93940, United States	Not yet recruiting	8313754105	Michael Zachary Koontz Principal Investigator
Banner MD Anderson Cancer Center at North Colorado Medical Center \| Greeley, Colorado, 80631, United States	Not yet recruiting	970-810-4416	Esther Mondo Principal Investigator
Rocky Mountain Cancer Center \| Lone Tree, Colorado, 80124, United States	Recruiting	303-388-4876	Ling Ma Principal Investigator
Banner MD Anderson Cancer Center at McKee Medical Center \| Loveland, Colorado, 80538, United States	Not yet recruiting	970-810-4416	Esther Mondo Principal Investigator
Florida Cancer Specialists \| Fort Myers, Florida, 33901-8101, United States	Not yet recruiting	239-274-9930	Vance M. Wright-Browne Principal Investigator
Univ of Florida School of Medicine \| Gainesville, Florida, 32610, United States	Recruiting	352-273-7832	Karen C Daily Weinstein Principal Investigator
Florida Cancer Specialists \| Saint Petersburg, Florida, 33705, United States	Not yet recruiting	7272161143	Sunil Girdharlal Gandhi Principal Investigator
Florida Cancer Specialists \| West Palm Beach, Florida, 33401, United States	Not yet recruiting	561-366-4100	Marilyn Raymond Principal Investigator
Kaiser Permanente Moanalua Medical Center \| Honolulu, Hawaii, 96819, United States	Recruiting	808-432-8000	Jennifer F Carney Principal Investigator
Rush University Medical Center \| Chicago, Illinois, 60612, United States	Recruiting	312-942-3324	Ruta Rao Principal Investigator
University of Chi Med Center \| Chicago, Illinois, 60637, United States	Not yet recruiting	773-702-6712	Gini F. Fleming Principal Investigator
Minnesota Oncology/Hematology PA \| Coon Rapids, Minnesota, 55433, United States	Recruiting	612-884-6300	Timothy G. Larson Principal Investigator
Broome Oncology \| Binghamton, New York, 13905, United States	Recruiting	Ronald P Harris Principal Investigator
Columbia University Medical Center \| New York, New York, 10032, United States	Not yet recruiting	212-305-1945	Meghna Trivedi Principal Investigator
Memorial Sloan Kettering Cancer Center \| New York, New York, 10065, United States	Not yet recruiting	646-888-5145	Komal Jhaveri Principal Investigator
Aultman Hospital \| Canton, Ohio, 44710, United States	Recruiting	330-438-6333	Shruti Trehan Principal Investigator
Zangmeister Cancer Center \| Columbus, Ohio, 43219, United States	Not yet recruiting	614-383-6000	Jeanna L Knoble Principal Investigator
Willamette Valley Cancer Institute & Research Ctr. \| Eugene, Oregon, 97401, United States	Not yet recruiting	541-683-5001	Keith Wells Principal Investigator
Avera Cancer Institute \| Sioux Falls, South Dakota, 57105, United States	Not yet recruiting	605-322-3981	Jason Jones Principal Investigator
Sarah Cannon Research Institute SCRI \| Nashville, Tennessee, 37203, United States	Not yet recruiting	615-329-7274	SMO Sarah Cannon Research Inst. Principal Investigator
Texas Oncology - Austin Central \| Austin, Texas, 78731, United States	Recruiting	512-427-9400	Debra A Patt Principal Investigator
Texas Oncology - Carrollton \| Carrollton, Texas, 75010, United States	Recruiting	972-537-4100	Vibha T Thomas Principal Investigator
Texas Oncology - Medical City Dallas \| Dallas, Texas, 75230, United States	Recruiting	972-566-4291	Jay Courtright Principal Investigator
Texas Oncology - Dallas Presbyterian Hospital \| Dallas, Texas, 75231, United States	Recruiting	214-739-4175	Kristi J McIntyre Principal Investigator
Texas Oncology - Methodist Charlton Cancer Center \| Dallas, Texas, 75237, United States	Recruiting	214-943-9911	Inna Shmerlin Principal Investigator
Texas Oncology-Baylor Charles A. Sammons Cancer Center \| Dallas, Texas, 75246, United States	Recruiting	214-370-1000	Joyce A. O'Shaughnessy Principal Investigator
Texas Oncology - Denison \| Denison, Texas, 75020, United States	Recruiting	903-868-4783	Tammy E Roque Principal Investigator
Texas Oncology Denton \| Denton, Texas, 76201, United States	Recruiting	940-382-1022	Charles V Kurkul Principal Investigator
Texas Oncology Fort Worth \| Fort Worth, Texas, 76104, United States	Recruiting	817-413-1500	Chi M Pham Principal Investigator
Texas Oncology - Willowbrook \| Houston, Texas, 77070, United States	Not yet recruiting	Haris Baig Principal Investigator
Texas Oncology - McKinney \| McKinney, Texas, 75071, United States	Recruiting	972-542-8609	Monte F Jones Principal Investigator
Texas Oncology - Paris \| Paris, Texas, 75460, United States	Recruiting	903-785-0031	Sucharu Prakash Principal Investigator
Texas Oncology-Plano East \| Plano, Texas, 75075, United States	Recruiting	9728673577	Christopher T.F. Stokoe Principal Investigator
Texas Oncology - San Antonio Medical Center \| San Antonio, Texas, 78240, United States	Recruiting	210-656-7177	Sharon T Wilks Principal Investigator
Texas Oncology - The Woodlands \| The Woodlands, Texas, 77380, United States	Recruiting	281-296-0365	Paula Ryan Principal Investigator
US Oncology \| The Woodlands, Texas, 77380, United States	Not yet recruiting	SMO US Oncology Principal Investigator
Utah Cancer Specialists \| Salt Lake City, Utah, 84106, United States	Recruiting	8014621053	Stephan DiSean Kendall Principal Investigator
University of Vermont Medical Center \| Burlington, Vermont, 05401, United States	Not yet recruiting	603-650-8626	Peter A Kaufman Principal Investigator
Blue Ridge Cancer Care \| Salem, Virginia, 24153, United States	Recruiting	540-774-8660	Amanda L Gillespie-Twardy Principal Investigator
Fundación CENIT para la Investigación en Neurociencias \| Caba, BA, C1125ABD, Argentina	Recruiting	5491133147765	Mónica Casalnuovo Principal Investigator
Instituto de Investigaciones Clínicas Mar del Plata \| Mar del Plata, Buenos Aires, 7600, Argentina	Recruiting	5492235937663	Ignacio Casarini Principal Investigator
CIPREC \| Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, C1119ACN, Argentina	Recruiting	5491150523121	Ezequiel Hernan Slutsky Principal Investigator
Clinica Viedma \| Viedma, Río Negro, R8500ACE, Argentina	Recruiting	54 2920428700 ext 170	Gabriela Guaygua Loayza Principal Investigator
Instituto Argentino de Diagnóstico y Tratamiento (IADT) \| Buenos Aires, 1122, Argentina	Recruiting	(+54 911) 4162-5353	Juan Esteban Cundom Principal Investigator
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC \| Cordoba, X5008HHW, Argentina	Recruiting	543514766837	Jorge Emilio Salinas Principal Investigator
Instituto San Marcos \| San Juan, 5400, Argentina	Recruiting	+54 0264 422 2935	Alvaro Nahuel Nahuel Yanzi Castilla Principal Investigator
Sanatorio Norte \| Santiago del Estero, 4200, Argentina	Recruiting	5491165820007	Víctor Agustín Paz Povedano Principal Investigator
St Vincent's Hospital \| Darlinghurst, New South Wales, 2010, Australia	Recruiting	0293555652	Elgene Lim Principal Investigator
Princess Alexandra Hospital \| Woolloongabba, Queensland, 4102, Australia	Not yet recruiting	Wen Xu Principal Investigator
Cancer Research SA \| Adelaide, South Australia, 5000, Australia	Recruiting	61870702513	Meena Okera Principal Investigator
Box Hill Hospital \| Box Hill, Victoria, 3128, Australia	Not yet recruiting	Angelyn Anton Principal Investigator
Universitätsklinikum Graz \| Graz, Steiermark, 8036, Austria	Recruiting	4331638581082	Edgar Petru Principal Investigator
Private Practice - Dr. Hubalek \| Schwaz, Tirol, 6130, Austria	Recruiting	0524265529	Michael Hubalek Principal Investigator
Medizinische Universität Wien \| Vienna, Wien, 1090, Austria	Recruiting	4314040028010	Christian Singer Principal Investigator
Universitätsklinikum Salzburg \| Salzburg, 5020, Austria	Recruiting	00435725525823	Richard Greil Principal Investigator
Imelda General Hospital \| Bonheiden, Antwerpen, 2820, Belgium	Not yet recruiting	015505011	Wim Wynendaele Principal Investigator
UZ Brussel \| Brussels, Bruxelles-Capitale, Région De, 1090, Belgium	Recruiting	32024776415	Christel Fontaine Principal Investigator
UZ Gent \| Gent, Oost-Vlaanderen, 9000, Belgium	Not yet recruiting	3293322692	Hannelore Denys Principal Investigator
AZ Nikolaas \| Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium	Recruiting	3237602975	Ines Deleu Principal Investigator
AZ Groeninge Campus Kennedylaan \| Kortrijk, West-Vlaanderen, 8500, Belgium	Recruiting	3256633943	Laure Nuytemans Principal Investigator
Institut Jules Bordet \| Brussel, 1000, Belgium	Not yet recruiting	3225413188	Philippe Aftimos Principal Investigator
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg \| Leuven, 3000, Belgium	Not yet recruiting	3216345129	Patrick Neven Principal Investigator
Hospital de Cancer de Londrina \| Londrina, Paraná, 86015-520, Brazil	Recruiting	(43)98818-4847	Éverton Araújo Melo Principal Investigator
Faculdade de Medicina do ABC \| Santo Andre, SP, 09060-650, Brazil	Not yet recruiting	551149935491	Patricia Xavier Santi Principal Investigator
Icesp - Instituto Do Câncer Do Estado de São Paulo \| São Paulo, 01246-000, Brazil	Not yet recruiting	5511999028129	Marcela Simonis Martins Ferrari Principal Investigator
Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA \| São Paulo, 01317-000, Brazil	Recruiting	551123598425	André Mattar Principal Investigator
IBCC - Instituto Brasileiro de Controle do Câncer \| São Paulo, 04014-002, Brazil	Recruiting	551134744222	Larissa Lopes Paula Principal Investigator
Afflilated Hospital of Bengbu Medical College \| Bengbu, Anhui, 233004, China	Not yet recruiting	13095520028	Gongsheng Jin Principal Investigator
The Fifth Medical Center of PLA General Hospital \| Beijing, Beijing, 100071, China	Not yet recruiting	13901372170	Zefei Jiang Principal Investigator
Beijing Cancer hospital \| Beijing, Beijing, 100142, China	Not yet recruiting	86 13811012595	Huiping Li Principal Investigator
Guangdong Provincial People's Hospital \| Guangzhou, Guangdong, 510080, China	Not yet recruiting	+86 13802910639	Ning Liao Principal Investigator
Sun Yat-sen Memorial Hospital, Sun Yat-sen University \| Guangzhou, Guangdong, 510120, China	Not yet recruiting	+86 189 2218 2851	Qiang Liu Principal Investigator
Hainan Cancer Hospital \| Haikou, Hainan, 570000, China	Not yet recruiting	+86 18876162185	Xia Liu Principal Investigator
Cangzhou Central Hospital \| Cangzhou, Hebei, 061001, China	Not yet recruiting	13315777876	Guozhong Cui Principal Investigator
Harbin Medical University Cancer Hospital \| Harbin, Heilongjiang, 150081, China	Not yet recruiting	8613313612989	Qingyuan Zhang Principal Investigator
Henan Cancer Hospital \| Zhengzhou, Henan, 450008, China	Not yet recruiting	15713857388	Min Yan Principal Investigator
Hubei Cancer Hospital \| Wuhan, Hubei, 430079, China	Not yet recruiting	1367777777	Xinhong Wu Principal Investigator
The First People's Hospital of Changde City \| Changde, Hunan, 415003, China	Not yet recruiting	86 15873644000	Tao Wu Principal Investigator
Hunan Provincial People's Hospital \| ChangSha, Hunan, 410005, China	Not yet recruiting	86 13873187373	Peizhi Fan Principal Investigator
Xiangya Hospital Central South University \| Changsha, Hunan, 410008, China	Not yet recruiting	86 18229944886	Juan Huang Principal Investigator
Inner Mongolia People's Hospital \| Hohhot, Inner Mongolia, 010017, China	Not yet recruiting	18047191088	Wenxin Li Principal Investigator
The Third Hospital of Nanchang \| Nanchang, Jiangxi, 330009, China	Not yet recruiting	0791-86728121	Hong Wang Principal Investigator
Jilin Cancer Hospital \| Changchun, Jilin, 130000, China	Not yet recruiting	0431-85536383	Ying Cheng Principal Investigator
The Second Hospital of Jilin University \| Changchun, Jilin, China	Not yet recruiting	Jingwei Xu Principal Investigator
Jiangsu Province Hospital \| Nanjing, Nanjing, 210029, China	Not yet recruiting	13705163889	Jinhai Tang Principal Investigator
Jinan Central Hospital \| Jinan, Shandong, 250013, China	Not yet recruiting	111111	Meili Sun Principal Investigator
West China Hospital of Sichuan University \| Cheng Du, Sichuan, 610041, China	Not yet recruiting	18980601830	Hong Zheng Principal Investigator
Xinjiang Medical University Cancer Hospital - Urumqi \| Urumqi, Xinjiang, 830000, China	Not yet recruiting	Bing Zhao Principal Investigator
Sir Run Run Shaw Hospital \| Hangzhou, Zhejiang, 310016, China	Not yet recruiting	86 15857121122	Xian Wang Principal Investigator
Zhejiang Cancer Hospital \| Hangzhou, Zhejiang, 310022, China	Not yet recruiting	13906500190	Xiaojia Wang Principal Investigator
Sichuan Cancer Hospital \| Chengdu, 610041, China	Not yet recruiting	13518204307	Hao WANG Principal Investigator
Jining Medical University - Affiliated Hospital \| Jining, 272029, China	Not yet recruiting	Changping Shan Principal Investigator
Tianjin Medical University Cancer Institute & Hospital \| Tianjin, 300060, China	Not yet recruiting	86 22 23340123 ext.2002	Zhongsheng Tong Principal Investigator
Thomayerova nemocnice \| Prague, Praha 4 - Krč, 14059, Czechia	Not yet recruiting	420734236410	Tomas Buchler Principal Investigator
Nemocnice Na Bulovce \| Prague, Praha 8, 180 81, Czechia	Not yet recruiting	0420266084512	Petra Holeckova Principal Investigator
Nemocnice Horovice \| Horovice, 268 01, Czechia	Not yet recruiting	420311559823	Martin Smakal Principal Investigator
Fakultni nemocnice Kralovske Vinohrady \| Praha 10, 100 34, Czechia	Not yet recruiting	420267163562	Milan Brychta Principal Investigator
Oblastní nemocnice Příbram, a.s. \| Pribram, 261 01, Czechia	Not yet recruiting	420606878528	Jitka Jakesova Principal Investigator
Institut de cancérologie Strasbourg Europe (ICANS) \| Strasbourg, Alsace, 67033, France	Recruiting	330368767154	Laura BENDER Principal Investigator
Centre de Cancérologie du Grand Montpellier \| Montpellier, Languedoc-Roussillon, 34070, France	Recruiting	33467926155	Cristian VILLANUEVA Principal Investigator
Centre Hospitalier de la Côte Basque \| Bayonne, Pyrénées-Atlantiques, 64109, France	Recruiting	33533788127	Thomas Grellety Principal Investigator
Polyclinique De Blois \| La Chaussee Saint Victor, 41260, France	Recruiting	33254906555	Philippe Laplaige Principal Investigator
Clinique Victor Hugo - Centre Jean Bernard \| Le Mans, 72000, France	Recruiting	33243297908	Hugues Bourgeois Principal Investigator
Institut Curie \| Paris, 75248, France	Recruiting	33147111515	François Clément Bidard Principal Investigator
Institut Curie \| Saint-Cloud, Île-de-France, 92210, France	Recruiting	33147111515	François Clément Bidard Principal Investigator
Universitätsklinikum Erlangen \| Erlangen, Bayern, 91054, Germany	Recruiting	4991318533572	Peter A Fasching Principal Investigator
Rotkreuzklinikum München - Frauenklinik (Gemeinnützige GmbH) \| München, Bayern, 80637, Germany	Recruiting	00498913033797	Michael Braun Principal Investigator
Klinikum der Universität München Großhadern \| München, Bayern, 81377, Germany	Recruiting	498951604317	Nadia Harbeck Principal Investigator
Agaplesion Markus Krankenhaus \| Frankfurt, Hessen, 60431, Germany	Recruiting	00496995332228	Marc Thill Principal Investigator
Gynäkologisch-Onkologische Praxis am Pelikanplatz \| Hannover, Niedersachsen, 30177, Germany	Recruiting	495116555280	Hans-Joachim Lück Principal Investigator
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung \| Essen, Nordrhein-Westfalen, 45136, Germany	Not yet recruiting	4920117433005	Mattea Reinisch Principal Investigator
Evangelisches Krankenhaus Bethesda Mönchengladbach \| Mönchengladbach, Nordrhein-Westfalen, 41061, Germany	Recruiting	4921615624857	Oleg Gluz Principal Investigator
Ostholstein Onkologie \| Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany	Recruiting	494361513632	Gerdt Huebner Principal Investigator
Agios Savvas Regional Cancer Hospital \| Athens, Attikí, 115 22, Greece	Not yet recruiting	+302106409639	Dimitrios Tryfonopoulos Principal Investigator
Alexandra Hospital \| Athens, Attikí, 115 28, Greece	Not yet recruiting	+306946462998	FLORA ZAGOURI Principal Investigator
University General Hospital of Heraklion \| Heraklion, Irakleío, 711 10, Greece	Not yet recruiting	2810-392750	Dimitrios Mavroudis Principal Investigator
Euromedica General Clinic of Thessaloniki \| Thessaloniki, Thessaloníki, 546 45, Greece	Recruiting	+306947330432	Konstantinos Papazisis Principal Investigator
European Interbalkan Medical Center \| Thessaloniki, Thessaloníki, 570 01, Greece	Not yet recruiting	302310400368	Sofia Baka Principal Investigator
General Hospital of Thessaloniki Papageorgiou \| Thessaloniki, 56403, Greece	Not yet recruiting	302313323134	Eleni Timotheadou Principal Investigator
Maulana Azad Medical College \| New Delhi, Delhi, 110002, India	Not yet recruiting	919968604364	Kishore Singh Principal Investigator
HCG-Bangalore \| Bengaluru, Karnataka, 560027, India	Not yet recruiting	Satheesh Chiradoni Thungappa Principal Investigator
Regional Cancer Centre - Thiruvananthapuram \| Thiruvananthapuram, Kerala, 695011, India	Not yet recruiting	04712522653	Rona Joseph Principal Investigator
HCG Cancer Centre \| Mumbai, Maharashtra, 400092, India	Not yet recruiting	Indoo Ambulkar Principal Investigator
Government Medical College And Hospital - Nagpur \| Nagpur, Maharashtra, 440003, India	Not yet recruiting	Ashok Diwan Principal Investigator
HCG Manavata Cancer Centre \| Nashik, Maharashtra, 422001, India	Not yet recruiting	9823061929	Rajnish Nagarkar Principal Investigator
Deenanath Mangeshkar Hospital & Research Centre \| Pune, Maharashtra, 411004, India	Not yet recruiting	919850811449	Chetan Dilip Deshmukh Principal Investigator
Yashoda Hospitals \| Hyderabad, Telangana, 500082, India	Not yet recruiting	9966596459	Nikhil Ghadyalpatil Principal Investigator
University of Naples Federico II \| Naples, Campania, 80100, Italy	Recruiting	390817463660	Sabino De Placido Principal Investigator
Istituto Nazionale Tumori IRCCS Fondazione Pascale \| Napoli, Campania, 80131, Italy	Recruiting	390815903699	Michelino De Laurentiis Principal Investigator
Cro-Irccs \| Aviano, Friuli-Venezia Giulia, 33081, Italy	Not yet recruiting	0434659253	Fabio Puglisi Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli \| Roma, Lazio, 00168, Italy	Not yet recruiting	0630158545	Ida Paris Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori \| Milano, MI, 20133, Italy	Not yet recruiting	390223902849	Giulia Bianchi Principal Investigator
Azienda Ospedaliera Universitaria Careggi \| Firenze, Toscana, 50134, Italy	Not yet recruiting	390557947264	Lorenzo Livi Principal Investigator
Ospedale San Martino \| Genova, 16132, Italy	Not yet recruiting	3901056006538	Lucia Del Mastro Principal Investigator
Istituto Europeo di Oncologia IRCCS \| Milano, 20141, Italy	Not yet recruiting	390257489970	Marco Angelo Colleoni Principal Investigator
Azienda Ospedaliero Universitaria \| Modena, 41125, Italy	Not yet recruiting	3286256343	Luca Moscetti Principal Investigator
Istituto Oncologico Veneto IRCCS \| Padova, 35128, Italy	Not yet recruiting	390498215931	Valentina Guarneri Principal Investigator
Nagoya University Hospital \| Nagoya, Aichi, 466-8560, Japan	Not yet recruiting	+81-527442251	Norikazu Masuda Principal Investigator
Chiba cancer center \| Chiba-shi, Chiba, 260-8717, Japan	Recruiting	81120023812	Rikiya Nakamura Principal Investigator
Kurume General Hospital \| Kurume, Fukuoka, 830-0013, Japan	Recruiting	81120023812	Miki Yamaguchi Principal Investigator
Gunma Prefectural Cancer Center \| Otashi, Gunma, 373-8550, Japan	Recruiting	81120023812	Yasuhiro Yanagita Principal Investigator
National Hospital Organization Hokkaido Cancer Center \| Sapporo, Hokkaido, 003-0804, Japan	Recruiting	81118119111	Mitsugu Yamamoto Principal Investigator
Hyogo Cancer Center \| Akashi, Hyogo, 673-8558, Japan	Recruiting	81120023812	Koji Matsumoto Principal Investigator
University of tsukuba hospital \| Tsukuba-shi, Ibaragi, 305-8576, Japan	Not yet recruiting	81120023812	Hiroko Bando Principal Investigator
St Marianna University School of Medicine Hospital \| Kawasaki, Kanagawa, 216-8511, Japan	Recruiting	81120023812	Koichiro Tsugawa Principal Investigator
Kanagawa cancer center \| Yokohama, Kanagawa, 241-8515, Japan	Not yet recruiting	81120023812	Toshinari Yamashita Principal Investigator
Juntendo University Hospital \| Bunkyo-ku, Tokyo, 113-8431, Japan	Recruiting	81120023812	Junichiro Watanabe Principal Investigator
National Cancer Center Hospital \| Chuo-ku, Tokyo, 104-0045, Japan	Not yet recruiting	81335422511	Tatsunori Shimoi Principal Investigator
Hiroshima City Hospital \| Hiroshima, 730-8518, Japan	Recruiting	81120023812	Mitsuya Itoh Principal Investigator
Sagara Hospital \| Kagoshima, 892-0833, Japan	Recruiting	81120023812	Tetsuhiko Taira Principal Investigator
Kumamoto Shinto General Hospital \| Kumamoto, 862-8655, Japan	Recruiting	81120023812	Reiki Nishimura Principal Investigator
Osaka International Cancer Institute \| Osaka, 541-8567, Japan	Not yet recruiting	81120023812	Takahiro Nakayama Principal Investigator
Shizuoka Prefectural General Hospital \| Shizuoka, 420-0881, Japan	Recruiting	81120023812	Michiko Tsuneizumi Principal Investigator
Soon Chun Hyang University Cheonan Hospital \| Cheonan-si, Chungcheongnam-do [Chungnam], 31151, Korea, Republic of	Recruiting	082-010-2529-3895	Han Jo Kim Principal Investigator
Gachon University Gil Hospital \| Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of	Recruiting	821099335099	Hee Kyung Ahn Principal Investigator
Severance Hospital, Yonsei University Health System \| Seoul, Korea, 03722, Korea, Republic of	Recruiting	82222288135	Joo Hyuk Sohn Principal Investigator
Ajou University Hospital \| Suwon-si, Kyǒnggi-do, 16499, Korea, Republic of	Recruiting	82312195989	Seok Yun Kang Principal Investigator
Yeungnam Univeristy Medical Center \| Gyeongsan-si, Kyǒngsangbuk-do, 42415, Korea, Republic of	Recruiting	82-10-9314-1980	Sung Ae Koh Principal Investigator
Dong-A University Hospital \| Busan, Pusan-Kwangyǒkshi, 49201, Korea, Republic of	Recruiting	01085095384	SUEE LEE Principal Investigator
Asan Medical Center \| Seoul, Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of	Recruiting	82230103217	Sung-Bae Kim Principal Investigator
Gangnam Severance Hospital \| Seoul, Seoul-teukbyeolsi [Seoul], 06273, Korea, Republic of	Recruiting	821087462662	Jee Hung Kim Principal Investigator
Seoul National University Hospital \| Seoul, Seoul-teukbyeolsi [Seoul], 3080, Korea, Republic of	Recruiting	82220720795	Seock-Ah Im Principal Investigator
Kangbuk Samsung Hospital \| Seoul, Seoul-teukbyeolsi [Seoul], 3181, Korea, Republic of	Recruiting	82 2 2001 1859	Yun-Gyoo Lee Principal Investigator
Samsung Medical Center \| Seoul, Seoul-teukbyeolsi [Seoul], 6351, Korea, Republic of	Recruiting	Yeon Hee Park Principal Investigator
Centro de Investigación Clínica de Alta Especialidad \| Torreón, Coahuila, 27010, Mexico	Recruiting	+52 871 7 14 47 35	ALMA MAGDALENA ASTORGA RAMOS Principal Investigator
Grupo Medico Camino Sc \| Mexico City, Distrito Federal, 03310, Mexico	Not yet recruiting	Maria de la Luz Garcia Principal Investigator
Christus Muguerza Clinica Vidriera (Christus Muguerza Sistemas Hospitalarios S.A. de C.V.) \| Monterrey Nuevo León, C.P., Monterrey, 64570, Mexico	Recruiting	+5218110623583	Jorge Luis Martinez Rodriguez Principal Investigator
COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F. \| Paso De Las Lomas, MX, 01330, Mexico	Recruiting	Manuel Ernesto Magallanes Maciel Principal Investigator
Private Practice - Dr. Joaquin Reinoso \| Monterrey, Nuevo León, 64320, Mexico	Recruiting	5283715413	Joaquin Gabriel Reinoso Toledo Principal Investigator
Centro Medico Zambrano Helion \| San Pedro Garza Garcia, Nuevo León, 66278, Mexico	Recruiting	5218120307335	Cynthia Villarreal-Garza Principal Investigator
Unidad de Investigación en Salud \| Chihuahua, 31203, Mexico	Recruiting	6143970186	Raul Gerardo Ramírez Principal Investigator
Oaxaca Site Management Organization \| Oaxaca, 68000, Mexico	Not yet recruiting	529515147056	Carlos Alberto Hernandez Hernandez Principal Investigator
Unidad Médica Onco-hematológica \| Puebla, 72424, Mexico	Recruiting	Eduardo Tellez Bernal Principal Investigator
Medische Centrum Leeuwarden \| Leeuwarden, Fryslân, 8934 AD, Netherlands	Not yet recruiting	31582866934	Hiltje de Graaf Principal Investigator
Maastricht UMC+ \| Maastricht, Limburg, 6229 HX, Netherlands	Not yet recruiting	31433877025	Maaike de Boer Principal Investigator
Haga Ziekenhuis locatie Leyweg \| Den Haag, Zuid-Holland, 2545 AA, Netherlands	Not yet recruiting	070 210 0000	Danny Houtsma Principal Investigator
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF \| Moscow, Moskva, 115478, Russian Federation	Not yet recruiting	74993249254	Inna Petrovna Ganshina Principal Investigator
N.N.Petrov Research Institute of Oncology \| Saint Petersburg, Sankt-Peterburg, 197758, Russian Federation	Not yet recruiting	79219597722	Petr Vladimirovich Krivorotko Principal Investigator
Volgograd Regional Clinical Cancer Clinic No.1 \| Volgograd, Volgogradskaya Oblast', 400138, Russian Federation	Not yet recruiting	79064060147	Nadezhda Vitalievna Kovalenko Principal Investigator
SHI Kaluga Regional Hospital \| Kaluga, 248007, Russian Federation	Recruiting	79066423777	Irina Rozhkova Principal Investigator
Hospital Universitari Vall d'Hebron \| Barcelona, Barcelona [Barcelona], 08035, Spain	Recruiting	934894350	Cristina Saura Manich Principal Investigator
Hospital de la Santa Creu i Sant Pau \| Barcelona, Catalunya [Cataluña], 8041, Spain	Recruiting	34935565638	Agusti Barnadas Principal Investigator
Hospital Universitari Arnau de Vilanova \| Lleida, Cataluña, 25198, Spain	Recruiting	696729451	Serafin Morales Murillo Principal Investigator
Hospital Universitario Ramón y Cajal \| Madrid, Madrid, Comunidad De, 28034, Spain	Recruiting	34913368263	Maria Fernandez Abad Principal Investigator
Hospital Universitario de Canarias \| San Cristobal de La laguna, Santa Cruz De Tenerife, 38320, Spain	Recruiting	34922678000	Josefina Cruz Jurado Principal Investigator
Hospital Universitario San Cecilio \| Granada, 18016, Spain	Recruiting	958840490	Isabel Blancas Principal Investigator
Hospital Clinico San Carlos \| Madrid, 28040, Spain	Recruiting	34913303000	Jose Angel Garcia Saenz Principal Investigator
Hospital Universitario Virgen Macarena \| Sevilla, 41009, Spain	Recruiting	34600162731	Fernando Henao Carrasco Principal Investigator
Hospital Universitario Virgen Del Rocio \| Sevilla, 41013, Spain	Recruiting	34955013066	Manuel Ruiz Borrego Principal Investigator
Hospital Clínico Universitario de Valencia \| Valencia, 46010, Spain	Recruiting	34963862600	Begona Bermejo de las Heras Principal Investigator
Hospital Quirón Salud Valencia \| Valencia, 46010, Spain	Recruiting	0034961041901	Antonio Llombart Cussac Principal Investigator
Chi Mei Hospital - Liouying Branch \| Tainan City, Tainan, 73657, Taiwan	Recruiting	+886-6-622-6999 ext.73132	Shang-Wen Chen Principal Investigator
Taichung Veterans General Hospital \| Taichung, 40705, ROC, Taiwan	Recruiting	0423592525	Chih-Chiang Hung Principal Investigator
National Cheng-Kung Uni. Hosp. \| Tainan, 704, Taiwan	Recruiting	+886-6-2353535 ext.4273	Kuo-Ting Lee Principal Investigator
National Taiwan University Hospital \| Taipei, 10002, Taiwan	Recruiting	886223123456ext65080	Chiun-Sheng Huang Principal Investigator
Koo Foundation Sun Yat-Sen Cancer Center \| Taipei, 112, Taiwan	Recruiting	+886-2-28970011 ext.1686	Chi-Feng Chung Principal Investigator
Acibadem Altunizade Hospital \| Üsküdar / Stanbul, İstanbul, Turkey	Recruiting	905326675589	Gul Basaran Principal Investigator
Ege University Medicine of Faculty \| Bornova, İzmir, 35100, Turkey	Recruiting	905337360674	Erhan Gokmen Principal Investigator
Baskent University Dr. Turgut Noyan Research and Training Center \| Adana, 01250, Turkey	Recruiting	905353067506	Ozgur Ozyilkan Principal Investigator
University of Health Sciences,Gulhane School of Medicine \| Ankara, 06010, Turkey	Recruiting	905366401020	Nuri Karadurmus Principal Investigator
Memorial Ankara Hastanesi \| Ankara, 06520, Turkey	Recruiting	+905067521275	Umut Demirci Principal Investigator
Ankara City Hospital \| Ankara, 06800, Turkey	Recruiting	905555306271	Mehmet Ali Nahit Sendur Principal Investigator
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital \| Ankara, 6200, Turkey	Recruiting	905055718475	Berna Oksuzoglu Principal Investigator
Hacettepe Universitesi \| Ankara, 6230, Turkey	Recruiting	905427212606	Sercan Aksoy Principal Investigator
Akdeniz University Medical Faculty \| Antalya, 07059, Turkey	Recruiting	905052312377	Sema Sezgin Goksu Principal Investigator
Dicle Üniversitesi \| Diyarbakir, 21200, Turkey	Recruiting	905337677131	Muhammet Ali Kaplan Principal Investigator
Trakya University \| Edirne, 22030, Turkey	Recruiting	905322480988	Irfan Cicin Principal Investigator
Medipol Mega University Hospital \| Istanbul, 34214, Turkey	Recruiting	905325280486	Ahmet Bilici Principal Investigator
Acıbadem Maslak Hastanesi \| İstanbul, 34457, Turkey	Recruiting	905062979770	Atakan Demir Principal Investigator
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi \| Istanbul, 34722, Turkey	Recruiting	00905063509061	Mahmut Gumus Principal Investigator
İnönü Üniversitesi Turgut Özal Tıp Merkezi \| Malatya, 44280, Turkey	Recruiting	905385003562	Hakan Harputluoglu Principal Investigator
Mersin University \| Mersin, 33343, Turkey	Recruiting	+905326334547	Emel Sezer Principal Investigator
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department \| Kryvyi Rih, Dnipropetrovska Oblast, 50048, Ukraine	Recruiting	380675393937	Hryhoriy Adamchuk Principal Investigator
CNPE "Regional Center of Oncology" \| Kharkiv, Kharkivska Oblast, 61070, Ukraine	Recruiting	380506556166	Dmytro Bukhtieiev Principal Investigator
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council \| Odesa, Odeska Oblast, 65025, Ukraine	Recruiting	380972147211	Oleksandr Berzoy Principal Investigator
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" \| Vinnytsia, Vinnytska Oblast, 21029, Ukraine	Recruiting	0432464635	Sergii Shevnya Principal Investigator
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council \| Lutsk, Volynska Oblast, 43018, Ukraine	Recruiting	380503782998	Ivan Sinielnikov Principal Investigator
Uzhgorod Central City Clinical Hospital \| Uzhhorod, Zakarpatska Oblast, 88000, Ukraine	Recruiting	380312640524	Yevhen Hotko Principal Investigator

Расположение Страны	Argentina Australia Austria Belgium Brazil China Czechia France Germany Greece India Italy Japan Korea, Republic of Mexico Netherlands Russian Federation Spain Taiwan Turkey Ukraine United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	SERD
Имеет расширенный доступ	No
Состояние Просмотр	Neoplasms Neoplasm Metastasis Breast Neoplasms
Количество рук	3
Группа вооружений	Метка: Imlunestrant Тип: Experimental Описание: Imlunestrant administered orally. Метка: Investigator's Choice of Endocrine Therapy Тип: Active Comparator Описание: Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). Метка: Imlunestrant plus Abemaciclib Тип: Experimental Описание: Imlunestrant plus abemaciclib administered orally.
Акроним	EMBER-3
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: None (Open Label)

A Study of Imlunestrant, Investigator