A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
MONARCH 3
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
3 other identifiers
interventional
493
21 countries
150
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Nov 2014
Longer than P75 for phase_3 breast-cancer
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedStudy Start
First participant enrolled
November 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedResults Posted
Study results publicly available
March 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 3, 2026
January 1, 2026
2.2 years
September 18, 2014
January 31, 2018
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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 Outcomes (12)
Overall Survival (OS)
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])
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Duration of Response (DoR)
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])
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])
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
- +7 more secondary outcomes
Study Arms (2)
Abemaciclib + NSAI
EXPERIMENTAL150 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).
Placebo + NSAI
PLACEBO COMPARATORPlacebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (155)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
CBCC Global Research, Inc.
Bakersfield, California, 93309, United States
California Cancer Associates Research and Excellence
Fresno, California, 93720, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California, 90024, United States
Central Coast Medical Oncology Corporation
Los Angeles, California, 90095, United States
Orlando Health, Inc
Los Angeles, California, 90095, United States
North Valley Hematology/Oncology Medical Group
Los Angeles, California, 95817, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Lakes Research, LLC
Miami Lakes, Florida, 33104, United States
Candler Medical Oncology Practice - Statesboro
Savannah, Georgia, 31404, United States
Candler Medical Oncology Practice - Statesboro
Savannah, Georgia, 31405, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, 68506, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Mount Sinai Cancer Center
New York, New York, 10011, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Oncology Consultants P.A.
Houston, Texas, 77030, United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Mater Adult Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, 3220, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universitaet Graz
Graz, Styria, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz
Linz, Upper Austria, 4020, Austria
Medizinische Universität Wien
Vienna, Vienna, 1090, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Vienna, 1090, Austria
Iridium Kankernetwerk Wilrijk en Antwerp
Wilrijk, Antwerpen, 2610, Belgium
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
Institut Jules Bordet
Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, 6000, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Hospital (Ontario)
Toronto, Ontario, M5G 2M9, Canada
Hopital Notre Dame
Montreal, Quebec, H2L 4M1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T
Montreal, Quebec, H4J 1C5, Canada
Hopital du Saint-Sacrement
Québec, G1S 4L8, Canada
Polyclinique Bordeaux Nord
Bordeaux, Aquitaine, 33077, France
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69008, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, 29200, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079, France
Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll
Saint-Brieuc, Côtes-d'Armor, 22027, France
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-Roussillon, 34070, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, 44805, France
Polyclinique de Gentilly
Nancy, Meurthe-et-Moselle, 54100, France
CHD Vendee
La Roche-sur-Yon, Vendée, 85000, France
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030, France
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89075, Germany
Klinikum Rechts der Isar der TU München
München, Bavaria, 81675, Germany
Helios Dr. Horst Schmidt Kliniken
Wiesbaden, Hesse, 65199, Germany
Marien-Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40479, Germany
Lübecker Onkologische Schwerpunktpraxis
Lübeck, Schleswig-Holstein, 23562, Germany
Facharztzentrum Eppendorf
Hamburg, 20249, Germany
Kath. Marienkrankenhaus gGmbH
Hamburg, 22087, Germany
Alexandra Hospital
Athens, Attikí, 11528, Greece
Rabin Medical Center
Petah Tikva, Central District, 49100, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Kaplan Medical Center
Rehovot, Central District, 7610001, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Rambam Health Care Campus
Haifa, Ḥeifā, 3109601, Israel
Ospedale Perrino
Brindisi, BR, 72100, Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona, Ferrara, 44124, Italy
Ospedale San Martino
Genoa, Liguria, 16132, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060, Italy
Nuovo Ospedale di Prato-S.Stefano
Prato, Tuscany, 59100, Italy
Ospedale Sacro Cuore Don G. Calabria
Negrar, Verona, 37024, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale Bellaria - Azienda USL di Bologna
Bologna, 40139, Italy
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
Messina, 98158, Italy
Policlinico Ospedale S. Andrea
Roma, 00189, Italy
Azienda Ospedaliera Santa Maria Terni
Terni, 05100, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Chiba cancer center
Chiba, Chiba, 260-8717, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 2418515, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Kindai University Hospital- Osakasayama Campus
Ōsaka-sayama, Osaka, 589-8511, Japan
Saitama Prefectural Cancer Center
Kitaadachi-Gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-8777, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329- 0498, Japan
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
Bunkyo-ku, Tokyo, 113-8677, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hiroshima City Hospital
Hiroshima, 730-8518, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
National Hospital Organization Osaka Medical Center
Osaka, 540-0006, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Clinica Oncológica San Francisco
Torreón, Coahuila, 27000, Mexico
Superare Centro de Infusion
México, Federal District, 06760, Mexico
Fundacion Rodolfo Padilla AC
León, Guanajuato, 37000, Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Hospital La Raza
Mexico City, Mexico City, 2990, Mexico
Grupo Medico Camino Sc
Mexico City, Mexico City, 3310, Mexico
Centro Oncologico Belenus
Cuernavaca, Morelos, 62290, Mexico
Centro de Estudios Y Prevencion Del Cancer
Juchitán de Zaragoza, Oaxaca, 70020, Mexico
Cancerología
Colinas Del Cimatario, Querétaro, 76090, Mexico
Haga Ziekenhuis locatie Leyweg
The Hague, South Holland, 2545 AA, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moscow, Moscow, 115478, Russia
European Medical Center
Moscow, Russian Federation, 129090, Russia
Clinic Complex
Saint Petersburg, Russian Federation, 190013, Russia
Republic Oncology Dispensary of MoH of Republic Tatarstan
Kaznan, Russia, 420029, Russia
Saint-Petersburg City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
Rosmedtech Scientific Research Institute of Oncology
Saint Petersburg, 197758, Russia
Onkologicky Ustav sv. Alzbety
Bratislava, Bratislava Region, 812 50, Slovakia
Vychodoslovensky Onkologicky ustav a.s.
Košice, Košice Region, 041-90, Slovakia
Inha University Hospital
Incheon, Incheon-gwangyeoksi [Incheon], 22332, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 3080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 3722, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 5505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 6351, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Taegu-Kwangyǒkshi, 41404, South Korea
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea
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.
Badajoz, 06080, Spain
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Barcelona, 08907, Spain
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Donostia / San Sebastian, 20014, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Valencia, 46015, Spain
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Gävle, 80187, Sweden
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Örebro, 70185, Sweden
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Västerås, SE-72189, Sweden
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Beidou, 112, Taiwan
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Kuei Shan Hsiang, 33305, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 100, Taiwan
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Zhonghe, 235, Taiwan
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Ankara, 06100, Turkey (Türkiye)
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Edirne, 22770, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Bebbington, CH63 4JY, United Kingdom
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Cambridge, CB20QQ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (6)
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.
PMID: 28968163RESULTJohnston 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.
PMID: 30675515RESULTHong 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.
PMID: 38470447DERIVEDRugo 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.
PMID: 36861085DERIVEDTakahashi 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.
PMID: 34661821DERIVEDGoetz 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.
PMID: 33392835DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 18, 2014
First Posted
September 23, 2014
Study Start
November 6, 2014
Primary Completion
January 31, 2017
Study Completion (Estimated)
December 1, 2026
Last Updated
February 3, 2026
Results First Posted
March 23, 2018
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.