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JOURNAL ONKOLOGIE – STUDIE
EMBER-3

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Rekrutierend

NCT-Nummer:
NCT04975308

Studienbeginn:
Oktober 2021

Letztes Update:
18.04.2024

Wirkstoff:
Imlunestrant, Exemestane, Fulvestrant, Abemaciclib

Indikation (Clinical Trials):
Neoplasms, Neoplasm Metastasis, Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Eli Lilly and Company

Collaborator:
-

Studienleiter

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

Kontakt

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 236)

Klinikum Ludwigsburg
71640 Ludwigsburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Onkologiezentrum Donauwörth
86609 Donauwörth
(Bayern)
GermanyAbgeschlossen» Google-Maps
Universitaetsklinikum Erlangen
91054 Erlangen
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
80336 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Gynäkologisches Krebszentrum Agaplesion Markus Krankenhaus Frankfurt
Wilhelm-Epstein-Straße 4
60431 Frankfurt am Main
DeutschlandRekrutierend» Google-Maps
Gynäkologisch-Onkologische Praxis am Pelikanplatz
30177 Hannover
(Niedersachsen)
GermanyAbgeschlossen» Google-Maps
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
45136 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Evangelisches Krankenhaus Bethesda Mönchengladbach
41061 Mönchengladbach
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Schleswig-Holstein Campus Kiel
24105 Kiel
(Schleswig-Holstein)
GermanyAbgeschlossen» Google-Maps
Ironwood Cancer & Research Centers
85224 Chandler
United StatesAbgeschlossen» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California Davis (UC Davis) Comprehensive Cancer Center
95817 Sacramento
United StatesAktiv, nicht rekrutierend» Google-Maps
Banner MD Anderson Cancer Center at McKee Medical Center
80538 Loveland
United StatesAbgeschlossen» Google-Maps
University of Florida College of Medicine
32610 Gainesville
United StatesAktiv, nicht rekrutierend» Google-Maps
Mid Florida Hematology and Oncology Center
32763 Orange City
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
33705 Saint Petersburg
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists
34232 Sarasota
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente Moanalua Medical Center
96819 Honolulu
United StatesAbgeschlossen» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
NorthShore University HealthSystem - Evanston Hospital
60201 Evanston
United StatesRekrutierend» Google-Maps
IU Health Ball Memorial Hospital, Inc.
47303 Muncie
United StatesAbgeschlossen» Google-Maps
The University of Louisville, James Graham Brown Cancer Center
40202 Louisville
United StatesRekrutierend» Google-Maps
Minnesota Oncology/Hematology PA
55433 Coon Rapids
United StatesAbgeschlossen» Google-Maps
Jackson Oncology Associates, PLLC
39202 Jackson
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering - Bergen
07645 Montvale
United StatesAktiv, nicht rekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
University of North Carolina Medical Center
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Avera Cancer Institute Sioux Falls
57105 Sioux Falls
United StatesAktiv, nicht rekrutierend» Google-Maps
Sarah Cannon Research Institute SCRI
37203 Nashville
United StatesRekrutierend» Google-Maps
Texas Oncology - Dallas Presbyterian Hospital
75231 Dallas
United StatesAbgeschlossen» Google-Maps
Texas Oncology Denton
76201 Denton
United StatesAktiv, nicht rekrutierend» Google-Maps
Willamette Valley Cancer Institute & Research Ctr.
77070 Houston
United StatesAbgeschlossen» Google-Maps
Broome Oncology
77380 The Woodlands
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Denison
77380 The Woodlands
United StatesAbgeschlossen» Google-Maps
Texas Oncology - San Antonio Medical Center
77380 The Woodlands
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - The Woodlands
77380 The Woodlands
United StatesAbgeschlossen» Google-Maps
Texas Oncology Denton
77380 The Woodlands
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology Fort Worth
77380 The Woodlands
United StatesAbgeschlossen» Google-Maps
Texas Oncology-Baylor Charles A. Sammons Cancer Center
77380 The Woodlands
United StatesAktiv, nicht rekrutierend» Google-Maps
Utah Cancer Specialists
84106 Salt Lake City
United StatesAbgeschlossen» Google-Maps
The University of Vermont Medical Center Inc.
05401 Burlington
United StatesAktiv, nicht rekrutierend» Google-Maps
Instituto de Investigaciones Clínicas Mar del Plata
B7600FZO Mar del Plata
ArgentinaAktiv, nicht rekrutierend» Google-Maps
CIPREC
C1061AAS Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Fundación Cenit Para La Investigación En Neurociencias
1125 Caba
ArgentinaAbgeschlossen» Google-Maps
Centro Medico Privado CEMAIC
X5008HHW Capital
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
1122 Buenos Aires
ArgentinaAbgeschlossen» Google-Maps
Instituto San Marcos
5400 San Juan
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Sanatorio Norte
4200 Santiago del Estero
ArgentinaAktiv, nicht rekrutierend» Google-Maps
St Vincent's Hospital
2010 Darlinghurst
AustraliaAktiv, nicht rekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaAbgeschlossen» Google-Maps
Cancer Research SA
5000 Adelaide
AustraliaAktiv, nicht rekrutierend» Google-Maps
Maroondah Hospital
3135 Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Medizinische Universität Graz
8036 Graz
AustriaAktiv, nicht rekrutierend» Google-Maps
Medizinische Universität Wien
1090 Vienna
AustriaAbgeschlossen» Google-Maps
Institut Jules Bordet
1000 Bruxelles
BelgiumAktiv, nicht rekrutierend» Google-Maps
AZ Nikolaas
B-9100 Sint-Niklaas
BelgiumAktiv, nicht rekrutierend» Google-Maps
AZ Groeninge Campus Kennedylaan
8500 Kortrijk
BelgiumAktiv, nicht rekrutierend» Google-Maps
Hospital de Cancer de Londrina
86015-520 Londrina
BrazilAktiv, nicht rekrutierend» Google-Maps
Faculdade de Medicina do ABC
09060-650 Santo André
BrazilAktiv, nicht rekrutierend» Google-Maps
Icesp - Instituto Do Câncer Do Estado de São Paulo
01246-000 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA
01317-001 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Núcleo de Pesquisa Clínica da Rede São Camilo
04014-002 São Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Afflilated Hospital of Bengbu Medical College
233004 Bengbu
ChinaRekrutierend» Google-Maps
Fifth Medical Center of PLA General Hospital
100039 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Provincial Cancer Hospital
350014 Fuzhou
ChinaRekrutierend» Google-Maps
Sun Yat-Sen University Cancer Centre
511400 Guangzhou
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Henan University of Science &Technology
471003 Luoyang
ChinaRekrutierend» Google-Maps
Nanyang Second General Hospital
473000 Nanyang
ChinaNoch nicht rekrutierend» Google-Maps
Tongji Hospital Tongji Medical,Science & Technology
430030 Wuhan
ChinaRekrutierend» Google-Maps
Renmin Hospital of Wuhan University
430060 Wuhan
ChinaRekrutierend» Google-Maps
The First People's Hospital of Changde City
415003 Changde
ChinaRekrutierend» Google-Maps
Hunan Provincial People's Hospital
410005 ChangSha
ChinaRekrutierend» Google-Maps
Xiangya Hospital Central South University
410008 Changsha
ChinaRekrutierend» Google-Maps
The Third Hospital of Nanchang
330009 Nanchang
ChinaRekrutierend» Google-Maps
The First Hospital of Jilin University
130021 Changchun
ChinaRekrutierend» Google-Maps
The Second Hospital of Jilin University
Changchun
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Jining Medical University - Affiliated Hospital
272100 Jining
ChinaRekrutierend» Google-Maps
The Second People's Hospital of Neijiang
641000 Neijiang
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University Cancer Institute and Hospital
300060 Tianjing
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University
310003 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Hwa Mei Hospital University of Chinese Academy of Sciences
315010 Ningbo
ChinaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady
10034 PRague
CzechiaRekrutierend» Google-Maps
Fakultni Thomayerova nemocnice
14059 Prague
CzechiaRekrutierend» Google-Maps
Oblastni nemocnice Pribram
261 01 Pribram
CzechiaAbgeschlossen» Google-Maps
Institut de cancérologie Strasbourg Europe (ICANS)
67033 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Polyclinique De Blois
41260 La Chaussée-Saint-Victor
FranceAbgeschlossen» Google-Maps
Institut Curie - site Saint-Cloud
92210 Saint-Cloud
FranceAktiv, nicht rekrutierend» Google-Maps
Centre de Cancérologie du Grand Montpellier
34070 Montpellier
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Victor Hugo Le Mans
72000 Le Mans
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de la Côte Basque
64109 Bayonne
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de Cancérologie de Lorraine Alexis Vautrin
54519 Vandoeuvre-lès-Nancy
FranceAbgeschlossen» Google-Maps
Agios Savvas Regional Cancer Hospital
115 22 Athens
GreeceAktiv, nicht rekrutierend» Google-Maps
Alexandra Hospital
115 28 Athens
GreeceAktiv, nicht rekrutierend» Google-Maps
General Oncology Hospital of Kifissia "Agioi Anargiroi"
14564 Nea Kifissia
GreeceRekrutierend» Google-Maps
University General Hospital of Heraklion
711 10 Heraklion
GreeceAktiv, nicht rekrutierend» Google-Maps
Euromedica General Clinic of Thessaloniki
546 45 Thessaloniki
GreeceAktiv, nicht rekrutierend» Google-Maps
Papageorgiou General Hospital of Thessaloniki
564 29 Thessaloniki
GreeceAbgeschlossen» Google-Maps
European Interbalkan Medical Center
570 01 Thessaloniki
GreeceAktiv, nicht rekrutierend» Google-Maps
University General Hospital of Larissa
41110 Larissa
GreeceAbgeschlossen» Google-Maps
Medstar Speciality Hospital
560092 Bangalore
IndiaAktiv, nicht rekrutierend» Google-Maps
Regional Cancer Centre - Thiruvananthapuram
695011 Thiruvananthapuram
IndiaAbgeschlossen» Google-Maps
Government Medical College And Hospital - Nagpur
440003 Nagpur
IndiaAktiv, nicht rekrutierend» Google-Maps
Rashtrasant Tukdoji Regional Cancer Hospital
440027 Nagpur
IndiaAktiv, nicht rekrutierend» Google-Maps
HCG Manavata Cancer Centre
422002 Nashik
IndiaAktiv, nicht rekrutierend» Google-Maps
Deenanath Mangeshkar Hospital & Research Centre
411004 Pune
IndiaAktiv, nicht rekrutierend» Google-Maps
Lifepoint Multispeciality Hospital
411057 Pune
IndiaAktiv, nicht rekrutierend» Google-Maps
University of Naples Federico II
80100 Naples
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione Pascale
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Ospedale San Martino
16132 Genova
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Careggi
50134 Firenze
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanRekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanRekrutierend» Google-Maps
Tsuchiura Kyodo General Hospital
300-0028 Tsuchiura
JapanRekrutierend» Google-Maps
Tsukuba University Hospital
305-8576 Tsukuba
JapanRekrutierend» Google-Maps
St. Marianna University School of Medicine Hospital
216-8511 Kawasaki
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata-shi
JapanRekrutierend» Google-Maps
Showa University Hospital
142-8555 Shinagawa
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Kumamoto Shinto General Hospital
862-8655 Kumamoto
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
Soon Chun Hyang University Cheonan Hospital
31151 Cheonan-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Namdong-gu
Korea, Republic ofAbgeschlossen» Google-Maps
Ajou University Hospital
16499 Suwon-si
Korea, Republic ofAbgeschlossen» Google-Maps
Yeungnam Univeristy Medical Center
42415 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Dong-A University Hospital
49201 Busan
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Kangbuk Samsung Hospital
03181 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Centro de Investigación Clínica de Alta Especialidad
27010 Torreón
MexicoAbgeschlossen» Google-Maps
Grupo Medico Camino Sc
03310 Mexico City
MexicoAktiv, nicht rekrutierend» Google-Maps
COI Centro Oncologico Internacional S.A.P.I. de C.V.
01330 Álvaro Obregón
MexicoAktiv, nicht rekrutierend» Google-Maps
Private Practice - Dr. Joaquin Reinoso
64320 Monterrey
MexicoAktiv, nicht rekrutierend» Google-Maps
Filios Alta Medicina
64460 Monterrey
MexicoAktiv, nicht rekrutierend» Google-Maps
Centro Medico Zambrano Hellion
66278 San Pedro Garza Garcia
MexicoAktiv, nicht rekrutierend» Google-Maps
Unidad de Investigación en Salud
31203 Chihuahua
MexicoAbgeschlossen» Google-Maps
Oaxaca Site Management Organization
68000 Oaxaca
MexicoAbgeschlossen» Google-Maps
Unidad Médica Onco-hematológica
72424 Puebla
MexicoAktiv, nicht rekrutierend» Google-Maps
Medische Centrum Leeuwarden
8934 AD Leeuwarden
NetherlandsAbgeschlossen» Google-Maps
Maastricht UMC+
6229 HX Maastricht
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Haga Ziekenhuis locatie Leyweg
2545 AA Den Haag
NetherlandsRekrutierend» Google-Maps
Kaluga Regional Clinical Oncology Center
248007 Kaluga
Russian FederationAbgeschlossen» Google-Maps
Volgograd Regional Clinical Cancer Clinic No.1
400138 Volgograd
Russian FederationRekrutierend» Google-Maps
N.N.Petrov Research Institute of Oncology
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari Dexeusa
08028 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital San Pedro de Alcántara
10003 Cáceres
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Arnau de Vilanova de Lleida
25198 Lleida
SpainAbgeschlossen» Google-Maps
Hospital Universitario Ramón y Cajal
28034 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 La Laguna
SpainAbgeschlossen» Google-Maps
Hospital Clinico de Valencia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Quirónsalud Valencia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario San Cecilio
18016 Granada
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico San Carlos
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen Macarena
41009 Sevilla
SpainAbgeschlossen» Google-Maps
Hospital Universitario Virgen Del Rocio
41013 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Chi Mei Hospital - Liouying Branch
73657 Tainan City
TaiwanAbgeschlossen» Google-Maps
Taichung Veterans General Hospital
407 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Cheng Kung University Hospital
704 Tainan
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Koo Foundation Sun Yat-Sen Cancer Center
112 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Medipol Mega Universite Hastanesi
34214 Stanbul
TurkeyAktiv, nicht rekrutierend» Google-Maps
Acibadem Altunizade Hospital
Üsküdar / Stanbul
TurkeyAktiv, nicht rekrutierend» Google-Maps
Baskent University Dr. Turgut Noyan Research and Training Center
01250 Adana
TurkeyAktiv, nicht rekrutierend» Google-Maps
Sbü Gülhane Eğitim Ve Araştirma Hastanesi
06010 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
06200 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Ankara City Hospital
06800 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Akdeniz Universitesi Hastanesi
07059 Antalya
TurkeyAktiv, nicht rekrutierend» Google-Maps
Acıbadem Maslak Hastanesi
34457 İstanbul
TurkeyAbgeschlossen» Google-Maps
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
34722 Istanbul
TurkeyAbgeschlossen» Google-Maps
İnönü Üniversitesi Turgut Özal Tıp Merkezi
44280 Malatya
TurkeyAbgeschlossen» Google-Maps
Mersin University
33343 Mersin
TurkeyAktiv, nicht rekrutierend» Google-Maps
Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
50048 Kryvyi Rih
UkraineRekrutierend» Google-Maps
CNPE "Regional Center of Oncology"
61070 Kharkiv
UkraineRekrutierend» Google-Maps
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
65025 Odesa
UkraineRekrutierend» Google-Maps
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
43018 Lutsk
UkraineRekrutierend» Google-Maps
Uzhgorod Central City Clinical Hospital
88000 Uzhhorod
UkraineRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population (Time Frame - Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)):
PFS by investigator assessment in the IIT population

2. PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population (Time Frame - Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)):
PFS by investigator assessment in ESR1-mutation detected population

Secondary outcome:

1. Overall Survival (OS) in the IIT Population (Time Frame - Randomization until death from any cause (estimated as up to 5 years)):
OS in the IIT population

2. OS in the ESR1-mutation Detected Population (Time Frame - Randomization until death from any cause (estimated as up to 5 years)):
OS in the ESR1-mutation detected population

3. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) (Time Frame - Randomization until measured progressive disease (estimated as up to 1 year)):
ORR

4. Duration of Response (DoR) (Time Frame - Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)):
DoR

5. 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 (Time Frame - Randomization until measured progressive disease (estimated as up to 1 year)):
CBR

6. Progression Free Survival (PFS) (Time Frame - Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)):
PFS by blinded independent review

7. Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" (Time Frame - Screening through follow-up (estimated as up to 3 years)):
Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."

8. Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant (Time Frame - Cycle 2 to Cycle 4 (cycle = 28 days)):
PK: steady state plasma concentrations of imlunestrant

9. PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib (Time Frame - Cycle 2 to Cycle 4 (cycle = 28 days)):
PK: steady state plasma concentrations of imlunestrant and abemaciclib

Studien-Arme

  • Experimental: Imlunestrant
    Imlunestrant administered orally.
  • Active Comparator: Investigator's Choice of Endocrine Therapy
    Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.
  • Experimental: Imlunestrant plus Abemaciclib
    Imlunestrant plus abemaciclib administered orally.

Geprüfte Regime

  • Imlunestrant (LY3484356):
    Administered orally.
  • Exemestane:
    Administered orally.
  • Fulvestrant:
    Administered IM.
  • Abemaciclib (LY2835219):
    Administered orally.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer"

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