A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer (MONARCH 3)
January 16, 2026 updated by: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
493
Phase
- Phase 3
Expanded Access
Approved for sale to the public.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Chris O'Brien Lifehouse
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Sydney, New South Wales, Australia, 2010
- St Vincent's Hospital
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Wahroonga, New South Wales, Australia, 2076
- Sydney Adventist Hospital
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Mater Adult Hospital Brisbane
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Woodville, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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Victoria
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Geelong, Victoria, Australia, 3220
- Barwon Health - The Geelong Hospital
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- St. John of God Murdoch Hospital
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Styria
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Graz, Styria, Austria, 8036
- Medizinische Universitaet Graz
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Medizinische Universitaet Innsbruck
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Ordensklinikum Linz
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Vienna
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Vienna, Vienna, Austria, 1090
- Universitaetsklinikum Allgemeines Krankenhaus Wien
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Vienna, Vienna, Austria, 1090
- Medizinische Universität Wien
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Charleroi, Belgium, 6000
- Grand Hopital de Charleroi-Site Notre-Dame
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Namur, Belgium, 5000
- CHU UCL Namur/Site Sainte Elisabeth
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Roeselare, Belgium, 8800
- AZ Delta
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Antwerpen
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Wilrijk, Antwerpen, Belgium, 2610
- Iridium Kankernetwerk Wilrijk en Antwerp
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Brussels Capital
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Brussels, Brussels Capital, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Bruxelles-Capitale, Région de
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Anderlecht, Bruxelles-Capitale, Région de, Belgium, 1070
- Institut Jules Bordet
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Québec, Canada, G1S 4L8
- Hôpital du Saint-Sacrement
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Oshawa, Ontario, Canada, L1G 2B9
- Lakeridge Health
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital - General Campus
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital (Ontario)
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, Canada, H2L 4M1
- Hopital Notre Dame
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Montreal, Quebec, Canada, H4J 1C5
- Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T
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Besançon, France, 25030
- CHU de Besancon Hopital Jean Minjoz
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Aquitaine
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Bordeaux, Aquitaine, France, 33077
- Polyclinique Bordeaux Nord
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, France, 69008
- Centre Léon Bérard
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Brittany Region
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Brest, Brittany Region, France, 29200
- Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
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Côte-d'Or
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Dijon, Côte-d'Or, France, 21079
- Centre Georges François Leclerc
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Côtes-d'Armor
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Saint-Brieuc, Côtes-d'Armor, France, 22027
- Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll
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Languedoc-Roussillon
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Montpellier, Languedoc-Roussillon, France, 34070
- Centre de Cancérologie du Grand Montpellier
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Loire-Atlantique
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Saint-Herblain, Loire-Atlantique, France, 44805
- Institut de Cancérologie de l'Ouest
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, France, 54100
- Polyclinique de Gentilly
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Vendée
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La Roche-sur-Yon, Vendée, France, 85000
- CHD Vendee
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Hamburg, Germany, 20249
- Facharztzentrum Eppendorf
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Hamburg, Germany, 22087
- Kath. Marienkrankenhaus gGmbH
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Baden-Wurttemberg
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Ludwigsburg, Baden-Wurttemberg, Germany, 71640
- Klinikum Ludwigsburg
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Ulm, Baden-Wurttemberg, Germany, 89075
- Universitätsklinikum Ulm
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Bavaria
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München, Bavaria, Germany, 81675
- Klinikum rechts der Isar der TU München
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Hesse
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Wiesbaden, Hesse, Germany, 65199
- Helios Dr. Horst Schmidt Kliniken
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Germany, 40479
- Marien-Hospital Düsseldorf
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23562
- Lübecker Onkologische Schwerpunktpraxis
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Attikí
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Athens, Attikí, Greece, 11528
- Alexandra Hospital
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Central District
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Petah Tikva, Central District, Israel, 49100
- Rabin Medical Center
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Ramat Gan, Central District, Israel, 5265601
- Sheba Medical Center
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Rehovot, Central District, Israel, 7610001
- Kaplan Medical Center
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Jerusalem
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Jerusalem, Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Ḥeifā
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Haifa, Ḥeifā, Israel, 3109601
- Rambam Health Care Campus
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Bergamo, Italy, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Bologna, Italy, 40139
- Ospedale Bellaria - Azienda USL di Bologna
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Messina, Italy, 98158
- Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
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Roma, Italy, 00189
- Policlinico Ospedale S. Andrea
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Terni, Italy, 05100
- Azienda Ospedaliera Santa Maria Terni
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BR
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Brindisi, BR, Italy, 72100
- Ospedale Perrino
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Ferrara
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Cona, Ferrara, Italy, 44124
- Azienda ospedaliero Universitaria di Ferrara
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Liguria
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Genoa, Liguria, Italy, 16132
- Ospedale San Martino
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Torino
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Candiolo, Torino, Italy, 10060
- Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
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Tuscany
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Prato, Tuscany, Italy, 59100
- Nuovo Ospedale di Prato-S.Stefano
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Verona
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Negrar, Verona, Italy, 37024
- Ospedale Sacro Cuore Don G. Calabria
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Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Hiroshima, Japan, 730-8518
- Hiroshima City Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Osaka, Japan, 540-0006
- National Hospital Organization Osaka Medical Center
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center Hospital
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Chiba
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Chiba, Chiba, Japan, 260-8717
- Chiba cancer center
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Hokkaido
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Sapporo, Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Hyōgo
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Nishinomiya, Hyōgo, Japan, 663-8501
- Hyogo College of Medicine
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Kanagawa
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Yokohama, Kanagawa, Japan, 2418515
- Kanagawa Cancer Center
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Niigata
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Niigata, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Osaka
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Ōsaka-sayama, Osaka, Japan, 589-8511
- Kindai University Hospital- Osakasayama Campus
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Saitama
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Kitaadachi-Gun, Saitama, Japan, 362-0806
- Saitama Prefectural Cancer Center
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Shizuoka
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Nakatogari, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tochigi
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Shimotsuke, Tochigi, Japan, 329- 0498
- Jichi Medical University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8677
- Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
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Koto, Tokyo, Japan, 135-8550
- Japanese Foundation for Cancer Research
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
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Coahuila
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Torreón, Coahuila, Mexico, 27000
- Clinica Oncológica San Francisco
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Federal District
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México, Federal District, Mexico, 06760
- Superare Centro de Infusion
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Guanajuato
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León, Guanajuato, Mexico, 37000
- Fundacion Rodolfo Padilla AC
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Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Hospital Civil Fray Antonio Alcalde
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Mexico City
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Mexico City, Mexico City, Mexico, 2990
- Hospital La Raza
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Mexico City, Mexico City, Mexico, 3310
- Grupo Medico Camino Sc
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Morelos
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Cuernavaca, Morelos, Mexico, 62290
- Centro Oncologico Belenus
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Oaxaca
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Juchitán de Zaragoza, Oaxaca, Mexico, 70020
- Centro de Estudios y Prevencion del Cancer
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Querétaro
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Colinas Del Cimatario, Querétaro, Mexico, 76090
- Cancerología
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Leiden, Netherlands, 2333 ZA
- Leids Universitair Medisch Centrum
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South Holland
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The Hague, South Holland, Netherlands, 2545 AA
- Haga Ziekenhuis locatie Leyweg
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Auckland, New Zealand, 1023
- Auckland City Hospital
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Saint Petersburg, Russia, 197022
- Saint-Petersburg City Clinical Oncology Dispensary
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Saint Petersburg, Russia, 197758
- Rosmedtech Scientific Research Institute of Oncology
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, Russia, 163045
- Arkhangelsk Clinical Oncological Dispensary
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Moscow
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Moscow, Moscow, Russia, 115478
- Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
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Russia
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Kaznan, Russia, Russia, 420029
- Republic Oncology Dispensary of MoH of Republic Tatarstan
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Russian Federation
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Moscow, Russian Federation, Russia, 129090
- European Medical Center
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Saint Petersburg, Russian Federation, Russia, 190013
- Clinic Complex
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Bratislava Region
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Bratislava, Bratislava Region, Slovakia, 812 50
- Onkologicky Ustav sv. Alzbety
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Košice Region
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Košice, Košice Region, Slovakia, 041-90
- Vychodoslovensky Onkologicky ustav a.s.
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Incheon-gwangyeoksi [Incheon]
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Incheon, Incheon-gwangyeoksi [Incheon], South Korea, 22332
- Inha University Hospital
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Kyǒnggi-do
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Goyang-si, Kyǒnggi-do, South Korea, 10408
- National Cancer Center
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Seongnam, Kyǒnggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3080
- Seoul National University Hospital
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Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3722
- Severance Hospital, Yonsei University Health System
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Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 5505
- Asan Medical Center
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Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 6351
- Samsung Medical Center
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Taegu-Kwangyǒkshi
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Daegu, Taegu-Kwangyǒkshi, South Korea, 41404
- Kyungpook National University Chilgok Hospital
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Ulsan-Kwangyǒkshi
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Ulsan, Ulsan-Kwangyǒkshi, South Korea, 44033
- Ulsan University Hospital
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Badajoz, Spain, 06080
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spain, 08907
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Donostia / San Sebastian, Spain, 20014
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lleida, Spain, 25198
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Spain, 28007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia, Spain, 46015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gävle, Sweden, 80187
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Västerås, Sweden, SE-72189
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Örebro, Sweden, 70185
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beidou, Taiwan, 112
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kuei Shan Hsiang, Taiwan, 33305
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwan, 40447
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taipei, Taiwan, 100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zhonghe, Taiwan, 235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ankara, Turkey (Türkiye), 06100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Edirne, Turkey (Türkiye), 22770
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Malatya, Turkey (Türkiye), 44280
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bebbington, United Kingdom, CH63 4JY
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cambridge, United Kingdom, CB20QQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manchester, United Kingdom, M20 4BX
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sutton, United Kingdom, SM2 5PT
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Chandler, Arizona, United States, 85224
- Ironwood Cancer & Research Centers
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Arkansas
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Springdale, Arkansas, United States, 72762
- Highlands Oncology Group
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California
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Bakersfield, California, United States, 93309
- CBCC Global Research, Inc.
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Fresno, California, United States, 93720
- California Cancer Associates Research and Excellence
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Los Angeles, California, United States, 90024
- TRIO-US (Translational Research in Oncology-US)
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Los Angeles, California, United States, 90095
- Central Coast Medical Oncology Corporation
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Los Angeles, California, United States, 90095
- Orlando Health, Inc
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Los Angeles, California, United States, 95817
- North Valley Hematology/Oncology Medical Group
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Santa Monica, California, United States, 90404
- UCLA Hematology/Oncology - Parkside
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
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Miami Lakes, Florida, United States, 33104
- Lakes Research, LLC
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Georgia
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Savannah, Georgia, United States, 31404
- Candler Medical Oncology Practice - Statesboro
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Savannah, Georgia, United States, 31405
- Candler Medical Oncology Practice - Statesboro
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester, Minnesota
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Nebraska Hematology-Oncology, P.C.
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Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada
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New York
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New York, New York, United States, 10011
- Mount Sinai Cancer Center
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Tennessee
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Knoxville, Tennessee, United States, 37920
- University of Tennessee Medical Center
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Texas
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Houston, Texas, United States, 77030
- Oncology Consultants P.A.
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Lubbock, Texas, United States, 79410
- Joe Arrington Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
- Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- Have postmenopausal status
- Have either measurable disease or nonmeasurable bone-only disease
- Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have adequate organ function
- Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
- Are able to swallow capsules
Exclusion Criteria:
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have inflammatory breast cancer
- Have clinical evidence or a history of central nervous system (CNS) metastasis
- Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
- Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment
- Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
- Have received prior treatment with everolimus
- Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
- Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
- Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
- Have had major surgery within 14 days prior to randomization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Abemaciclib + NSAI
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Administered orally
Other Names:
Administered orally
Administered orally
|
|
Placebo Comparator: Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Administered orally
Administered orally
Administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival (PFS)
Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause.
Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant.
If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
|
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)
|
OS defined as the time from first dose date to the date of death due to any cause.
For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
|
Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)
|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
|
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
|
Duration of Response (DoR)
Time Frame: CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)
|
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier.
CR and PR were defined using the RECIST v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
|
CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)
|
|
Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
|
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
|
Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.
CR, PR, or SD were defined using RECIST v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) * 100.
|
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
|
|
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Time Frame: Baseline, End of Study (Up to 32 Months)
|
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains(physical,role,cognitive,emotional, and social),global health status, and symptom scales of fatigue, pain, nausea and vomiting,dyspnea,loss of appetite,insomnia,constipation and diarrhea, and financial difficulties.Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent".
A linear transformation is applied to standardize the raw scores to range between 0 and 100 with higher score indicating better functioning.
For functional domains and global health status, higher scores represent a better level of functioning.
Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
|
Baseline, End of Study (Up to 32 Months)
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Time Frame: Baseline, End of Study (Up to 32 Months)
|
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties.
Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much."
A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines.
For symptoms scales, higher scores indicated greater symptom burden.
Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
|
Baseline, End of Study (Up to 32 Months)
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Time Frame: Baseline, End of Study (Up to 32 Months)
|
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss).
QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much".
All scores are converted to a 0 to 100 scale.
A higher score representing a higher ("better") level of functioning (BR23: body image, sexual functioning, future perspective), or a higher ("worse") level of symptoms.
Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
|
Baseline, End of Study (Up to 32 Months)
|
|
Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
Time Frame: Baseline, End of Study (Up to 32 Months)
|
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment.
Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.
Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients.
Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
|
Baseline, End of Study (Up to 32 Months)
|
|
Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
Time Frame: Baseline, End of Study (Up to 32 Months)
|
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.
The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS).
EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients.
Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
|
Baseline, End of Study (Up to 32 Months)
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
Time Frame: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
|
Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
|
|
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
Time Frame: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
|
PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20
|
Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Tredan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.
- Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, Toi M, Iwata H, Goetz MP. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019 Jan 17;5:5. doi: 10.1038/s41523-018-0097-z. eCollection 2019.
- Takahashi M, Tokunaga E, Mori J, Tanizawa Y, van der Walt JS, Kawaguchi T, Goetz MP, Toi M. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2022 Jan;29(1):174-184. doi: 10.1007/s12282-021-01295-0. Epub 2021 Oct 18.
- Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.
- Hong J, Chen T, Ouyang L, Du N, Li A, Zhou Z, Zhang H, Xia Z, Meng J. Cost-effectiveness comparison of dalpiciclib and abemaciclib combined with an aromatase inhibitor as first-line treatment for HR+/HER2- advanced breast cancer. Expert Rev Pharmacoecon Outcomes Res. 2024 Apr;24(4):559-566. doi: 10.1080/14737167.2024.2330542. Epub 2024 Mar 20.
- Rugo HS, Harmer V, O'Shaughnessy J, Jhaveri K, Tolaney SM, Cardoso F, Bardia A, Maheshwari VK, Tripathi S, Haftchenary S, Pathak P, Fasching PA. Quality of life with ribociclib versus abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison. Ther Adv Med Oncol. 2023 Feb 24;15:17588359231152843. doi: 10.1177/17588359231152843. eCollection 2023.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2014
Primary Completion (Actual)
January 31, 2017
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 18, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (Estimated)
September 23, 2014
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15417
- I3Y-MC-JPBM (Other Identifier: Eli Lilly and Company)
- 2014-001502-18 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.