Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
NCT ID: NCT05169567
Last Updated: 2026-01-16
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
368 participants
INTERVENTIONAL
2022-03-11
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Abemaciclib plus Fulvestrant
Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Abemaciclib
Administered orally.
Fulvestrant
Administered IM.
Arm B: Placebo plus Fulvestrant
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
Fulvestrant
Administered IM.
Placebo
Administered orally.
Interventions
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Abemaciclib
Administered orally.
Fulvestrant
Administered IM.
Placebo
Administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Torrance Memorial Physician Network / Cancer Care
Torrance, California, United States
PIH Health Hematology Medical Oncology
Whittier, California, United States
Rocky Mountain Cancer Center - Hale Parkway
Denver, Colorado, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
Fort Myers, Florida, United States
Millennium Oncology Research Clinic
Hollywood, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI
Sarasota, Florida, United States
Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI
West Palm Beach, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI
Baton Rouge, Louisiana, United States
Clinical Trials of SWLA
Lake Charles, Louisiana, United States
Central Maine Medical Center
Lewiston, Maine, United States
Mfsmc-Hjwci
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A. - Clinton
Clinton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
MGH Northshore Cancer Center
Danvers, Massachusetts, United States
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, United States
Dana-Farber Cancer Institute - Foxborough
Foxborough, Massachusetts, United States
Dana Farber Cancer Center Merrimack Valley
Methuen, Massachusetts, United States
Dana Farber Cancer Institute
Milford, Massachusetts, United States
Mass General Cancer Center
Newton, Massachusetts, United States
Dana Farber Cancer Institute
South Weymouth, Massachusetts, United States
Reliant Medical Group
Worcester, Massachusetts, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Dana Farber Cancer Center Londonderry
Londonderry, New Hampshire, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI
Nashville, Tennessee, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Denton
Denton, Texas, United States
Texas Oncology, P.A.
El Paso, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - McKinney
McKinney, Texas, United States
Woodlands Medical Specialists, PA
McKinney, Texas, United States
Woodlands Medical Specialists, PA
Mesquite, Texas, United States
Texas Oncology - Plano East
Plano, Texas, United States
Texas Oncology-Plano West
Plano, Texas, United States
Mays Cancer Center
San Antonio, Texas, United States
US Oncology
The Woodlands, Texas, United States
Texas Oncology - Tyler Cancer Center
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Intermountain Healthcare - St. George
St. George, Utah, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Fundación Cenit Para La Investigación En Neurociencias
CABA, Buenos Aires F.D., Argentina
Fundación Respirar
Buenos Aires, Buenos Air, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, Argentina
CER San Juan
San Juan, , Argentina
Algemeen Ziekenhuis klina
Brasschaat, Antwerpen, Belgium
Jessa Ziekenhuis
Hasselt, Limburg, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, , Belgium
Multiscan
Pardubice, Pardubický kraj, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Herlev and Gentofte Hospital
Copenhagen, Capital Region, Denmark
Regionshospitalet Gødstrup
Herning, Central Jutland, Denmark
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, France
CHRU de Brest
Brest, Finistère, France
Hôpital privé du Confluent SAS
Nantes, Loire-Atlantique, France
CHD Vendee
La Roche-sur-Yon, Vendée, France
University Hospital of Patras
Pátrai, Achaḯa, Greece
Alexandra Hospital
Athens, Attikí, Greece
University General Hospital of Heraklion
Heraklion, Irakleío, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Meir Medical Center
Kfar Saba, Central District, Israel
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel
Humanitas Istituto Clinico Catanese
Misterbianco, Catania, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia, Italy
Instituto Tumori Giovanni Paolo II
Bari, , Italy
Ospedale Misericordia di Grosseto
Grosseto, , Italy
Ospedale San Raffaele
Milan, , Italy
ASL Viterbo Ospedale Belcolle
Viterbo, , Italy
Centro de Investigacion en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, Mexico
COI Tijuana - Centro Oncológico Internacional
Tijuana, Estado de Baja California, Mexico
Centro Oncológico Internacional (COI)
Guadalajara, Jalisco, Mexico
Centro Regiomontano de Investigación
Monterrey, Nuevo León, Mexico
Oncologico Potosino, S.C.
San Luis Potosí City, San Luis Potosí, Mexico
Europejskie Centrum Zdrowia - Oddzial Onkologii
Otwock, Masovian Voivodeship, Poland
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Opole, Opole Voivodeship, Poland
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Kyungpook National University Chilgok Hospital
Daegu, Taegu-Kwangyǒkshi, South Korea
CHUAC-Hospital Teresa Herrera
A Coruña, A Coruña [La Coruña], Spain
Hospital Universitari Son Espases
Palma, Balears [Baleares], Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Región de, Spain
H.R.U Málaga - Hospital Materno-infantil
Málaga, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona [Tarragona], Spain
Hospital Universitario Doctor Peset
Valencia, Valenciana, Comunitat, Spain
Hospital Infanta Cristina
Badajoz, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario de Toledo
Toledo, , Spain
Karolinska Universitetssjukhuset Solna
Stockholm, Stockholms, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro Län [se-18], Sweden
Chi Mei Medical Center
Tainan, Tainan, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Taipei Tzu Chi General Hospital
New Taipei City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Izmir Medical Park Hospital
Cordaleo, İzmir, Turkey (Türkiye)
Necmettin Erbakan Meram Medical Fac.
Meram, Konya, Turkey (Türkiye)
Adana City Hospital
Adana, , Turkey (Türkiye)
Ankara Gülhane Eitim ve Aratrma Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, , Turkey (Türkiye)
Countries
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References
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Zapatero-Solana E, Ding Y, Pulliam N, de Dios A, Ortiz-Ruiz MJ, Lallena MJ. Models of Early Resistance to CDK4/6 Inhibitors Unveil Potential Therapeutic Treatment Sequencing. Int J Mol Sci. 2025 Mar 14;26(6):2643. doi: 10.3390/ijms26062643.
Kalinsky K, Bianchini G, Hamilton E, Graff SL, Park KH, Jeselsohn R, Demirci U, Martin M, Layman RM, Hurvitz SA, Sammons S, Kaufman PA, Munoz M, Lai JI, Knoderer H, Sandoval C, Chawla AR, Nguyen B, Zhou Y, Ravenberg E, Litchfield LM, Smyth L, Wander SA. Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial. J Clin Oncol. 2025 Mar 20;43(9):1101-1112. doi: 10.1200/JCO-24-02086. Epub 2024 Dec 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)
Other Identifiers
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I3Y-MC-JPEF
Identifier Type: OTHER
Identifier Source: secondary_id
2021-002301-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506771-10-00
Identifier Type: OTHER
Identifier Source: secondary_id
18238
Identifier Type: -
Identifier Source: org_study_id
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