Trial Title:
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
NCT ID:
NCT05169567
Condition:
Breast Neoplasm
Neoplasm Metastasis
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Fulvestrant
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
Administered orally.
Arm group label:
Arm A: Abemaciclib plus Fulvestrant
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
Administered IM.
Arm group label:
Arm A: Abemaciclib plus Fulvestrant
Arm group label:
Arm B: Placebo plus Fulvestrant
Intervention type:
Drug
Intervention name:
Placebo
Description:
Administered orally.
Arm group label:
Arm B: Placebo plus Fulvestrant
Summary:
This study will evaluate the effect of adding abemaciclib to fulvestrant for the
treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2-) breast cancer that progressed or recurred after previous treatment
with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation
could last up to 5 years, depending on how you and your tumor respond.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
- Have radiologic evidence of disease progression or recurrence either
- On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial
therapy for advanced disease, or
- On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET)
administered as adjuvant therapy for early stage breast cancer
- Must be deemed appropriate for treatment with ET
- If female, have a postmenopausal status by natural or surgical means or by ovarian
function suppression
- Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease
(measurable disease and/or nonmeasurable 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 visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have symptomatic or untreated central nervous system metastasis
- Have received any systemic therapy between disease recurrence/progression and study
screening
- Have received more than 1 line of therapy for advanced or metastatic disease.
- Have received prior chemotherapy for metastatic breast cancer (MBC)
- Have received prior treatment with fulvestrant, any investigational estrogen
receptor (ER)-directed therapy (including selective ER degraders [SERDs] and
non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin
(mTOR)-, or protein kinase B (AKT)-inhibitor
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Joseph's Hospital and Medical Center
Address:
City:
Phoenix
Zip:
85004
Country:
United States
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72762
Country:
United States
Facility:
Name:
Providence Medical Foundation
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Facility:
Name:
TRIO-US (Translational Research in Oncology-US)
Address:
City:
Los Angeles
Zip:
90024
Country:
United States
Facility:
Name:
Keck School of Medicine of USC
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Facility:
Name:
UCLA Hematology/Oncology - Parkside
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Facility:
Name:
Olive View-UCLA Medical Center
Address:
City:
Sylmar
Zip:
91342
Country:
United States
Facility:
Name:
Torrance Memorial Physician Network / Cancer Care
Address:
City:
Torrance
Zip:
90505
Country:
United States
Facility:
Name:
PIH Health Hematology Medical Oncology
Address:
City:
Whittier
Zip:
90602
Country:
United States
Facility:
Name:
Rocky Mountain Cancer Center - Hale Parkway
Address:
City:
Denver
Zip:
80220
Country:
United States
Facility:
Name:
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
Address:
City:
Fort Myers
Zip:
33901-8101
Country:
United States
Facility:
Name:
Millennium Oncology Research Clinic
Address:
City:
Hollywood
Zip:
33024
Country:
United States
Facility:
Name:
University of Miami Hospital and Clinics, Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
Woodlands Medical Specialists, PA
Address:
City:
Pensacola
Zip:
32503
Country:
United States
Facility:
Name:
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Facility:
Name:
Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Facility:
Name:
Winship Cancer Institute, Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Facility:
Name:
Northeast Georgia Medical Center
Address:
City:
Gainesville
Zip:
30501
Country:
United States
Facility:
Name:
Central Georgia Cancer Care
Address:
City:
Macon
Zip:
31201
Country:
United States
Facility:
Name:
Kapiolani Medical Center for Women and Children
Address:
City:
Honolulu
Zip:
96826
Country:
United States
Facility:
Name:
Ingalls Memorial Hospital
Address:
City:
Harvey
Zip:
60426
Country:
United States
Facility:
Name:
Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Facility:
Name:
Clinical Trials of SWLA
Address:
City:
Lake Charles
Zip:
70601
Country:
United States
Facility:
Name:
Central Maine Medical Center
Address:
City:
Lewiston
Zip:
04240
Country:
United States
Facility:
Name:
Mfsmc-Hjwci
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Facility:
Name:
Maryland Oncology Hematology, P.A. - Clinton
Address:
City:
Clinton
Zip:
20735
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
MGH Northshore Cancer Center
Address:
City:
Danvers
Zip:
01923
Country:
United States
Facility:
Name:
Southcoast Centers for Cancer Care
Address:
City:
Fairhaven
Zip:
02719
Country:
United States
Facility:
Name:
Dana-Farber Cancer Institute - Foxborough
Address:
City:
Foxboro
Zip:
02035
Country:
United States
Facility:
Name:
Dana Farber Cancer Center Merrimack Valley
Address:
City:
Methuen
Zip:
01844
Country:
United States
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Milford
Zip:
01757
Country:
United States
Facility:
Name:
Mass General Cancer Center
Address:
City:
Newton
Zip:
02462
Country:
United States
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
South Weymouth
Zip:
02190
Country:
United States
Facility:
Name:
Reliant Medical Group
Address:
City:
Worcester
Zip:
01606
Country:
United States
Facility:
Name:
St. Vincent Frontier Cancer Center
Address:
City:
Billings
Zip:
59102
Country:
United States
Facility:
Name:
Dana Farber Cancer Center Londonderry
Address:
City:
Londonderry
Zip:
03053
Country:
United States
Facility:
Name:
University of New Mexico Comprehensive Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Facility:
Name:
Lifespan Cancer Institute
Address:
City:
Providence
Zip:
02906
Country:
United States
Facility:
Name:
Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI
Address:
City:
Chattanooga
Zip:
37404
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute/SCRI
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Texas Oncology - Bedford
Address:
City:
Bedford
Zip:
76022
Country:
United States
Facility:
Name:
Texas Oncology - Denton
Address:
City:
Denton
Zip:
76201
Country:
United States
Facility:
Name:
Texas Oncology, P.A.
Address:
City:
El Paso
Zip:
79902
Country:
United States
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4009
Country:
United States
Facility:
Name:
Texas Oncology - McKinney
Address:
City:
McKinney
Zip:
75071
Country:
United States
Facility:
Name:
Woodlands Medical Specialists, PA
Address:
City:
McKinney
Zip:
75071
Country:
United States
Facility:
Name:
Woodlands Medical Specialists, PA
Address:
City:
Mesquite
Zip:
75150
Country:
United States
Facility:
Name:
Texas Oncology - Plano East
Address:
City:
Plano
Zip:
75075-7787
Country:
United States
Facility:
Name:
Texas Oncology-Plano West
Address:
City:
Plano
Zip:
75093
Country:
United States
Facility:
Name:
Mays Cancer Center
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
US Oncology
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Facility:
Name:
Texas Oncology - Tyler Cancer Center
Address:
City:
Tyler
Zip:
75702
Country:
United States
Facility:
Name:
Intermountain Medical Center
Address:
City:
Murray
Zip:
84107
Country:
United States
Facility:
Name:
Intermountain Healthcare - St. George
Address:
City:
Saint George
Zip:
84790
Country:
United States
Facility:
Name:
The University of Vermont Medical Center Inc.
Address:
City:
Burlington
Zip:
05401
Country:
United States
Facility:
Name:
Shenandoah Oncology, P.C.
Address:
City:
Winchester
Zip:
22601
Country:
United States
Facility:
Name:
Fundación Respirar
Address:
City:
Buenos Aires
Zip:
C1426ABP
Country:
Argentina
Facility:
Name:
Centro de Investigaciones Metabólicas (CINME)
Address:
City:
Ciudad Autónoma de Buenos Aire
Zip:
C1027AAP
Country:
Argentina
Facility:
Name:
Fundación Cenit Para La Investigación En Neurociencias
Address:
City:
Caba
Zip:
1125
Country:
Argentina
Facility:
Name:
Instituto Médico Río Cuarto
Address:
City:
Río Cuarto
Zip:
5800
Country:
Argentina
Facility:
Name:
Centro Medico San Roque
Address:
City:
San Miguel de Tucumán
Zip:
4000
Country:
Argentina
Facility:
Name:
CER San Juan
Address:
City:
San Juan
Zip:
5400
Country:
Argentina
Facility:
Name:
Algemeen Ziekenhuis klina
Address:
City:
Brasschaat
Zip:
2930
Country:
Belgium
Facility:
Name:
Jessa Ziekenhuis
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Facility:
Name:
CHU UCL Namur/Site Sainte Elisabeth
Address:
City:
Namur
Zip:
5000
Country:
Belgium
Facility:
Name:
Multiscan
Address:
City:
Pardubice
Zip:
53203
Country:
Czechia
Facility:
Name:
Fakultni nemocnice Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
500 05
Country:
Czechia
Facility:
Name:
Herlev and Gentofte Hospital
Address:
City:
Copenhagen
Zip:
2730
Country:
Denmark
Facility:
Name:
Regionshospitalet Gødstrup
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Facility:
Name:
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Facility:
Name:
CHRU de Brest
Address:
City:
Brest
Zip:
29609
Country:
France
Facility:
Name:
Hôpital privé du Confluent SAS
Address:
City:
Nantes
Zip:
44277
Country:
France
Facility:
Name:
CHD Vendee
Address:
City:
La Roche-sur-Yon
Zip:
85000
Country:
France
Facility:
Name:
University Hospital of Patras
Address:
City:
Patras
Zip:
26504
Country:
Greece
Facility:
Name:
Alexandra Hospital
Address:
City:
Athens
Zip:
115 28
Country:
Greece
Facility:
Name:
University General Hospital of Heraklion
Address:
City:
Heraklion
Zip:
711 10
Country:
Greece
Facility:
Name:
Euromedica General Clinic of Thessaloniki
Address:
City:
Thessaloniki
Zip:
546 45
Country:
Greece
Facility:
Name:
Bacs-Kiskun Megyei Korhaz
Address:
City:
Kecskemét
Zip:
6000
Country:
Hungary
Facility:
Name:
Petz Aladar Egyetemi Oktato Korhaz
Address:
City:
Gyor
Zip:
9024
Country:
Hungary
Facility:
Name:
Magyar Honvedseg Egeszsegugyi Kozpont
Address:
City:
Budapest
Zip:
1062
Country:
Hungary
Facility:
Name:
Országos Onkológiai Intézet
Address:
City:
Budapest
Zip:
1122
Country:
Hungary
Facility:
Name:
Soroka Medical Center
Address:
City:
Be'er Sheva
Zip:
8400000
Country:
Israel
Facility:
Name:
Meir Medical Center
Address:
City:
Kfar Saba
Zip:
4428164
Country:
Israel
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah-Tikva
Country:
Israel
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Facility:
Name:
Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Facility:
Name:
Humanitas Istituto Clinico Catanese
Address:
City:
Misterbianco
Zip:
95045
Country:
Italy
Facility:
Name:
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Facility:
Name:
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Address:
City:
Udine
Zip:
33100
Country:
Italy
Facility:
Name:
Instituto Tumori Giovanni Paolo II
Address:
City:
Bari
Zip:
70124
Country:
Italy
Facility:
Name:
Ospedale Misericordia di Grosseto
Address:
City:
Grosseto
Zip:
58100
Country:
Italy
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
ASL Viterbo Ospedale Belcolle
Address:
City:
Viterbo
Zip:
01100
Country:
Italy
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Facility:
Name:
Centro de Investigacion en Artritis y Osteoporosis SC
Address:
City:
Mexicali
Zip:
21200
Country:
Mexico
Facility:
Name:
COI Tijuana - Centro Oncológico Internacional
Address:
City:
Tijuana
Zip:
22010
Country:
Mexico
Facility:
Name:
Centro Oncológico Internacional (COI)
Address:
City:
Guadalajara
Zip:
45647
Country:
Mexico
Facility:
Name:
Centro Regiomontano de Investigación
Address:
City:
Monterrey
Zip:
64060
Country:
Mexico
Facility:
Name:
Oncologico Potosino, S.C.
Address:
City:
San Luis Potosi
Zip:
78209
Country:
Mexico
Facility:
Name:
Europejskie Centrum Zdrowia - Oddzial Onkologii
Address:
City:
Otwock
Zip:
05-400
Country:
Poland
Facility:
Name:
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Address:
City:
Opole
Zip:
45-060
Country:
Poland
Facility:
Name:
CHUAC-Hospital Teresa Herrera
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Facility:
Name:
Hospital Universitari Son Espases
Address:
City:
Palma
Zip:
07120
Country:
Spain
Facility:
Name:
Parc de Salut Mar - Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Hospital Clínico Universitario Virgen de la Arrixaca
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Facility:
Name:
H.R.U Málaga - Hospital Materno-infantil
Address:
City:
Malaga
Zip:
29011
Country:
Spain
Facility:
Name:
Complejo Hospitalario de Navarra
Address:
City:
Pamplona
Zip:
31009
Country:
Spain
Facility:
Name:
Hospital Universitari Sant Joan de Reus
Address:
City:
Reus
Zip:
43204
Country:
Spain
Facility:
Name:
Hospital Universitario Doctor Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Facility:
Name:
Hospital Infanta Cristina
Address:
City:
Badajoz
Zip:
06006
Country:
Spain
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Facility:
Name:
Hospital Universitario de Toledo
Address:
City:
Toledo
Zip:
45007
Country:
Spain
Facility:
Name:
Karolinska Universitetssjukhuset Solna
Address:
City:
Stockholm
Zip:
171 76
Country:
Sweden
Facility:
Name:
Universitetssjukhuset Örebro
Address:
City:
Örebro
Zip:
701 85
Country:
Sweden
Facility:
Name:
Chi Mei Medical Center
Address:
City:
Tainan City
Zip:
71004
Country:
Taiwan
Facility:
Name:
Kaohsiung Medical University Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Facility:
Name:
Taipei Tzu Chi General Hospital
Address:
City:
New Taipei City
Zip:
231
Country:
Taiwan
Facility:
Name:
Mackay Memorial Hospital
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Facility:
Name:
Chang Gung Medical Foundation-Linkou Branch
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Facility:
Name:
Izmir Medical Park Hospital
Address:
City:
Karsiyaka
Zip:
009035575
Country:
Turkey
Facility:
Name:
Necmettin Erbakan Meram Medical Fac.
Address:
City:
Meram
Zip:
42080
Country:
Turkey
Facility:
Name:
Adana City Hospital
Address:
City:
Adana
Zip:
01370
Country:
Turkey
Facility:
Name:
Ankara Gülhane Eitim ve Aratrma Hastanesi
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Facility:
Name:
Memorial Ankara Hastanesi
Address:
City:
Ankara
Zip:
06520
Country:
Turkey
Facility:
Name:
Dicle Üniversitesi
Address:
City:
Diyarbakir
Zip:
21200
Country:
Turkey
Facility:
Name:
Trakya University
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Facility:
Name:
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Facility:
Name:
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Address:
City:
Malatya
Zip:
44280
Country:
Turkey
Start date:
March 11, 2022
Completion date:
February 16, 2026
Lead sponsor:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05169567
https://trials.lillytrialguide.com/en-US/trial/3dpA0zpCRcFApMyAER3V1o
