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

NCT ID: NCT02246621

Last Updated: 2026-02-03

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

493 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-06

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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).

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Anastrozole

Intervention Type DRUG

Administered orally

Letrozole

Intervention Type DRUG

Administered orally

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).

Group Type PLACEBO_COMPARATOR

Anastrozole

Intervention Type DRUG

Administered orally

Letrozole

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Abemaciclib

Administered orally

Intervention Type DRUG

Anastrozole

Administered orally

Intervention Type DRUG

Letrozole

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

CBCC Global Research, Inc.

Bakersfield, California, United States

Site Status

California Cancer Associates Research and Excellence

Fresno, California, United States

Site Status

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, United States

Site Status

Central Coast Medical Oncology Corporation

Los Angeles, California, United States

Site Status

Orlando Health, Inc

Los Angeles, California, United States

Site Status

North Valley Hematology/Oncology Medical Group

Los Angeles, California, United States

Site Status

UCLA Hematology/Oncology - Parkside

Santa Monica, California, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Lakes Research, LLC

Miami Lakes, Florida, United States

Site Status

Candler Medical Oncology Practice - Statesboro

Savannah, Georgia, United States

Site Status

Candler Medical Oncology Practice - Statesboro

Savannah, Georgia, United States

Site Status

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Site Status

Nebraska Hematology-Oncology, P.C.

Lincoln, Nebraska, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Mount Sinai Cancer Center

New York, New York, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Oncology Consultants P.A.

Houston, Texas, United States

Site Status

Joe Arrington Cancer Center

Lubbock, Texas, United States

Site Status

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Site Status

St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Site Status

Mater Adult Hospital Brisbane

South Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Site Status

Barwon Health - The Geelong Hospital

Geelong, Victoria, Australia

Site Status

St. John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Site Status

Medizinische Universitaet Graz

Graz, Styria, Austria

Site Status

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Ordensklinikum Linz

Linz, Upper Austria, Austria

Site Status

Medizinische Universität Wien

Vienna, Vienna, Austria

Site Status

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Vienna, Austria

Site Status

Iridium Kankernetwerk Wilrijk en Antwerp

Wilrijk, Antwerpen, Belgium

Site Status

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Site Status

Institut Jules Bordet

Anderlecht, Bruxelles-Capitale, Région de, Belgium

Site Status

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, , Belgium

Site Status

CHU UCL Namur/Site Sainte Elisabeth

Namur, , Belgium

Site Status

AZ Delta

Roeselare, , Belgium

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Lakeridge Health

Oshawa, Ontario, Canada

Site Status

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

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Princess Margaret Hospital (Ontario)

Toronto, Ontario, Canada

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Hopital Notre Dame

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

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

Montreal, Quebec, Canada

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Hopital du Saint-Sacrement

Québec, , Canada

Site Status

Polyclinique Bordeaux Nord

Bordeaux, Aquitaine, France

Site Status

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Brittany Region, France

Site Status

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Site Status

Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll

Saint-Brieuc, Côtes-d'Armor, France

Site Status

Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-Roussillon, France

Site Status

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-Atlantique, France

Site Status

Polyclinique de Gentilly

Nancy, Meurthe-et-Moselle, France

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CHD Vendee

La Roche-sur-Yon, Vendée, France

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CHU de Besancon Hopital Jean Minjoz

Besançon, , France

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Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Site Status

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

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Klinikum Rechts der Isar der TU München

München, Bavaria, Germany

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Helios Dr. Horst Schmidt Kliniken

Wiesbaden, Hesse, Germany

Site Status

Marien-Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Lübecker Onkologische Schwerpunktpraxis

Lübeck, Schleswig-Holstein, Germany

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Facharztzentrum Eppendorf

Hamburg, , Germany

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Kath. Marienkrankenhaus gGmbH

Hamburg, , Germany

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Alexandra Hospital

Athens, Attikí, Greece

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Rabin Medical Center

Petah Tikva, Central District, Israel

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Sheba Medical Center

Ramat Gan, Central District, Israel

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Kaplan Medical Center

Rehovot, Central District, Israel

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Hadassah Medical Center

Jerusalem, Jerusalem, Israel

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Soroka Medical Center

Beersheba, , Israel

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Meir Medical Center

Kfar Saba, , Israel

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

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Rambam Health Care Campus

Haifa, Ḥeifā, Israel

Site Status

Ospedale Perrino

Brindisi, BR, Italy

Site Status

Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, Italy

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Ospedale San Martino

Genoa, Liguria, Italy

Site Status

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

Candiolo, Torino, Italy

Site Status

Nuovo Ospedale di Prato-S.Stefano

Prato, Tuscany, Italy

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Ospedale Sacro Cuore Don G. Calabria

Negrar, Verona, Italy

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Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Site Status

Ospedale Bellaria - Azienda USL di Bologna

Bologna, , Italy

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Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

Messina, , Italy

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Policlinico Ospedale S. Andrea

Roma, , Italy

Site Status

Azienda Ospedaliera Santa Maria Terni

Terni, , Italy

Site Status

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Site Status

Chiba cancer center

Chiba, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Site Status

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

Site Status

Kanagawa cancer center

Yokohama, Kanagawa, Japan

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Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status

Kindai University Hospital- Osakasayama Campus

Ōsaka-sayama, Osaka, Japan

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Saitama Prefectural Cancer Center

Kitaadachi-Gun, Saitama, Japan

Site Status

Shizuoka Cancer Center

Nakatogari, Shizuoka, Japan

Site Status

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

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Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

Bunkyo-ku, Tokyo, Japan

Site Status

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

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Hiroshima City Hospital

Hiroshima, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

National Hospital Organization Osaka Medical Center

Osaka, , Japan

Site Status

Osaka International Cancer Institute

Osaka, , Japan

Site Status

Clinica Oncológica San Francisco

Torreón, Coahuila, Mexico

Site Status

Superare Centro de Infusion

México, Federal District, Mexico

Site Status

Fundacion Rodolfo Padilla AC

León, Guanajuato, Mexico

Site Status

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

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Hospital La Raza

Mexico City, Mexico City, Mexico

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Grupo Medico Camino Sc

Mexico City, Mexico City, Mexico

Site Status

Centro Oncologico Belenus

Cuernavaca, Morelos, Mexico

Site Status

Centro de Estudios Y Prevencion Del Cancer

Juchitán de Zaragoza, Oaxaca, Mexico

Site Status

Cancerología

Colinas Del Cimatario, Querétaro, Mexico

Site Status

Haga Ziekenhuis locatie Leyweg

The Hague, South Holland, Netherlands

Site Status

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Arkhangelskaya oblast, Russia

Site Status

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

Moscow, Moscow, Russia

Site Status

European Medical Center

Moscow, Russian Federation, Russia

Site Status

Clinic Complex

Saint Petersburg, Russian Federation, Russia

Site Status

Republic Oncology Dispensary of MoH of Republic Tatarstan

Kaznan, Russia, Russia

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Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Site Status

Rosmedtech Scientific Research Institute of Oncology

Saint Petersburg, , Russia

Site Status

Onkologicky Ustav sv. Alzbety

Bratislava, Bratislava Region, Slovakia

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Vychodoslovensky Onkologicky ustav a.s.

Košice, Košice Region, Slovakia

Site Status

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

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National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

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Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

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Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, Taegu-Kwangyǒkshi, South Korea

Site Status

Ulsan University Hospital

Ulsan, Ulsan-Kwangyǒkshi, South Korea

Site Status

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, , Spain

Site Status

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, , Spain

Site Status

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, , Spain

Site Status

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, , Spain

Site Status

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, , Spain

Site Status

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, , Spain

Site Status

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, , Sweden

Site Status

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, , Sweden

Site Status

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, , Sweden

Site Status

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, , Taiwan

Site Status

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, , Taiwan

Site Status

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, , Taiwan

Site Status

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, , Taiwan

Site Status

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, , Taiwan

Site Status

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, , Turkey (Türkiye)

Site Status

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, , Turkey (Türkiye)

Site Status

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, , Turkey (Türkiye)

Site Status

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, , United Kingdom

Site Status

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, , United Kingdom

Site Status

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, , United Kingdom

Site Status

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, , United Kingdom

Site Status

Countries

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United States Australia Austria Belgium Canada France Germany Greece Israel Italy Japan Mexico Netherlands New Zealand Russia Slovakia South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

References

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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.

Reference Type RESULT
PMID: 28968163 (View on PubMed)

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.

Reference Type RESULT
PMID: 30675515 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38470447 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36861085 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34661821 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33392835 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol: JPBM Protocol (a)

View Document

Document Type: Study Protocol: JPBM Protocol (b)

View Document

Document Type: Study Protocol: JPBM Protocol

View Document

Document Type: Statistical Analysis Plan: SAP V5 Addendum

View Document

Document Type: Statistical Analysis Plan: SAP V5

View Document

Related Links

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Other Identifiers

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I3Y-MC-JPBM

Identifier Type: OTHER

Identifier Source: secondary_id

2014-001502-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15417

Identifier Type: -

Identifier Source: org_study_id

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