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AzTrials

Breast CancerPhase 3MONARCH 3NCT02246621

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

A Phase 3 study testing Abemaciclib, Anastrozole and Letrozole in people with Breast Cancer, run by Eli Lilly and Company at 155 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Abemaciclib, Anastrozole and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
493 participants
Where
155 sitesin 22 countries
Study dates
6 Nov 2014to Dec 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

155 sites in 22 countries.

155 sites in 22 countries

United States20 sites

  • CBCC Global Research, Inc.

    Bakersfield, California, 93309

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • California Cancer Associates Research and Excellence

    Fresno, California, 93720

  • Oncology Consultants P.A.

    Houston, Texas, 77030

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Nebraska Hematology-Oncology, P.C.

    Lincoln, Nebraska, 68506

  • TRIO-US (Translational Research in Oncology-US)

    Los Angeles, California, 90024

  • Central Coast Medical Oncology Corporation

    Los Angeles, California, 90095

  • Orlando Health, Inc

    Los Angeles, California, 90095

  • North Valley Hematology/Oncology Medical Group

    Los Angeles, California, 95817

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410

  • Lakes Research, LLC

    Miami Lakes, Florida, 33104

  • Mount Sinai Cancer Center

    New York, New York, 10011

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California, 90404

  • Candler Medical Oncology Practice - Statesboro

    Savannah, Georgia, 31404

  • Candler Medical Oncology Practice - Statesboro

    Savannah, Georgia, 31405

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

Other trials in United States

Japan19 sites

  • Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

    Bunkyo-ku, Tokyo, 113-8677

  • Chiba cancer center

    Chiba, Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima City Hospital

    Hiroshima, 730-8518

  • Saitama Prefectural Cancer Center

    Kitaadachi-Gun, Saitama, 362-0806

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center

    Nakatogari, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501

  • National Hospital Organization Osaka Medical Center

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital- Osakasayama Campus

    Ōsaka-sayama, Osaka, 589-8511

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329- 0498

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Kanagawa cancer center

    Yokohama, Kanagawa, 2418515

Other trials in Japan

Italy11 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Ospedale Bellaria - Azienda USL di Bologna

    Bologna, 40139

  • Ospedale Perrino

    Brindisi, BR, 72100

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060

  • Azienda Ospedaliero Universitaria di Ferrara

    Cona, Ferrara, 44124

  • Ospedale San Martino

    Genoa, Liguria, 16132

  • Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

    Messina, 98158

  • Ospedale Sacro Cuore Don G. Calabria

    Negrar, Verona, 37024

  • Nuovo Ospedale di Prato-S.Stefano

    Prato, Tuscany, 59100

  • Policlinico Ospedale S. Andrea

    Roma, 00189

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

Other trials in Italy

France10 sites

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030

  • Polyclinique Bordeaux Nord

    Bordeaux, Aquitaine, 33077

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

    Brest, Brittany Region, 29200

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • CHD Vendee

    La Roche-sur-Yon, Vendée, 85000

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-Roussillon, 34070

  • Polyclinique de Gentilly

    Nancy, Meurthe-et-Moselle, 54100

  • Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll

    Saint-Brieuc, Côtes-d'Armor, 22027

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-Atlantique, 44805

Other trials in France

Mexico9 sites

  • Cancerología

    Colinas Del Cimatario, Querétaro, 76090

  • Centro Oncologico Belenus

    Cuernavaca, Morelos, 62290

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Centro de Estudios Y Prevencion Del Cancer

    Juchitán de Zaragoza, Oaxaca, 70020

  • Fundacion Rodolfo Padilla AC

    León, Guanajuato, 37000

  • Superare Centro de Infusion

    México, Federal District, 06760

  • Hospital La Raza

    Mexico City, Mexico City, 2990

  • Grupo Medico Camino Sc

    Mexico City, Mexico City, 3310

  • Clinica Oncológica San Francisco

    Torreón, Coahuila, 27000

Other trials in Mexico

South Korea9 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-Kwangyǒkshi, 41404

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

  • Inha University Hospital

    Incheon, Incheon-gwangyeoksi [Incheon], 22332

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 5505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033

Other trials in South Korea

Australia8 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Barwon Health - The Geelong Hospital

    Geelong, Victoria, 3220

  • St. John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • Mater Adult Hospital Brisbane

    South Brisbane, Queensland, 4101

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada8 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hopital Notre Dame

    Montreal, Quebec, H2L 4M1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T

    Montreal, Quebec, H4J 1C5

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Hopital du Saint-Sacrement

    Québec, G1S 4L8

  • Princess Margaret Hospital (Ontario)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany8 sites

  • Marien-Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40479

  • Facharztzentrum Eppendorf

    Hamburg, 20249

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, 22087

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, Schleswig-Holstein, 23562

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Klinikum Rechts der Isar der TU München

    München, Bavaria, 81675

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

  • Helios Dr. Horst Schmidt Kliniken

    Wiesbaden, Hesse, 65199

Other trials in Germany

Israel8 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, Central District, 49100

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

  • Kaplan Medical Center

    Rehovot, Central District, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Russia7 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Republic Oncology Dispensary of MoH of Republic Tatarstan

    Kaznan, Russia, 420029

  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

    Moscow, Moscow, 115478

  • European Medical Center

    Moscow, Russian Federation, 129090

  • Clinic Complex

    Saint Petersburg, Russian Federation, 190013

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • Rosmedtech Scientific Research Institute of Oncology

    Saint Petersburg, 197758

Other trials in Russia

Belgium6 sites

  • Institut Jules Bordet

    Anderlecht, Bruxelles-Capitale, Région de, 1070

  • Cliniques universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • Grand Hopital de Charleroi-Site Notre-Dame

    Charleroi, 6000

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000

  • AZ Delta

    Roeselare, 8800

  • Iridium Kankernetwerk Wilrijk en Antwerp

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Spain6 sites

  • 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

  • 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.

    Barcelona, 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.

    Donostia / San Sebastian, 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.

    Lleida, 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.

    Madrid, 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.

    Valencia, 46015

Other trials in Spain

Austria5 sites

  • Medizinische Universitaet Graz

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz

    Linz, Upper Austria, 4020

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

Taiwan5 sites

  • 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.

    Beidou, 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.

    Kuei Shan Hsiang, 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.

    Taichung, 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.

    Taipei, 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.

    Zhonghe, 235

Other trials in Taiwan

United Kingdom4 sites

  • 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.

    Bebbington, 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.

    Cambridge, 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.

    Manchester, 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.

    Sutton, SM2 5PT

Other trials in United Kingdom

Sweden3 sites

  • 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.

    Gävle, 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.

    Örebro, 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.

    Västerås, SE-72189

Other trials in Sweden

Turkey (Türkiye)3 sites

  • 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.

    Ankara, 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.

    Edirne, 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.

    Malatya, 44280

Other trials in Turkey (Türkiye)

Netherlands2 sites

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Haga Ziekenhuis locatie Leyweg

    The Hague, South Holland, 2545 AA

Other trials in Netherlands

Slovakia2 sites

  • Onkologicky Ustav sv. Alzbety

    Bratislava, Bratislava Region, 812 50

  • Vychodoslovensky Onkologicky ustav a.s.

    Košice, Košice Region, 041-90

Other trials in Slovakia

Greece1 site

  • Alexandra Hospital

    Athens, Attikí, 11528

Other trials in Greece

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
Abemaciclib, Anastrozole, Letrozole, Placebo
Keywords
MONARCH 3
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02246621
Study groupRoleWhat they receive
Abemaciclib + NSAIExperimental150 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).
Receives: Drug: Abemaciclib; Drug: Anastrozole; Drug: Letrozole
Placebo + NSAIPlacebo comparatorPlacebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Receives: Drug: Anastrozole; Drug: Letrozole; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

Secondary outcomes (12)

  1. Overall Survival (OS)

    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.

    Measured: Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)

  2. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

    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.

    Measured: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

  3. Duration of Response (DoR)

    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.

    Measured: CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)

  4. Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])

    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.

    Measured: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

  5. Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])

    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.

    Measured: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

  6. 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

    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.

    Measured: Baseline, End of Study (Up to 32 Months)

  7. Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores

    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.

    Measured: Baseline, End of Study (Up to 32 Months)

  8. Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire

    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.

    Measured: Baseline, End of Study (Up to 32 Months)

  9. Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value

    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.

    Measured: Baseline, End of Study (Up to 32 Months)

  10. Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale

    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.

    Measured: Baseline, End of Study (Up to 32 Months)

  11. 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

    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

    Measured: 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

  12. PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20

    PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2014 (estimated)
  2. Study start6 Nov 2014
  3. Primary completion31 Jan 2017
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246621
Sponsor's protocol ID
15417
Other IDs
I3Y-MC-JPBM, 2014-001502-18, 2014
Acronym
MONARCH 3
Status last verified
Jan 2026
First submitted
18 Sep 2014
Last updated
3 Feb 2026
Data monitoring committee
Yes
Individual data sharing
Yes: 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.
Expanded access
Available

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.

    PubMed 28968163

  • 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.

    PubMed 30675515

  • 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.

    PubMed 38470447

  • 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.

    PubMed 36861085

  • 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.

    PubMed 34661821

  • 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.

    PubMed 33392835

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib, Anastrozole and Letrozole in people with Breast Cancer, run by Eli Lilly and Company at 155 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Japan, Italy, France, Mexico and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02246621, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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