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ACTIVE NOT RECRUITING

NCT02246621

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

493

Start Date

2014-11-06

Completion Date

2026-12

Last Updated

2026-02-03

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

Abemaciclib

Administered orally

DRUG

Anastrozole

Administered orally

DRUG

Letrozole

Administered orally

DRUG

Placebo

Administered orally

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

Locations (155)

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

CBCC Global Research, Inc.

Bakersfield, California, United States

California Cancer Associates Research and Excellence

Fresno, California, United States

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, United States

Central Coast Medical Oncology Corporation

Los Angeles, California, United States

Orlando Health, Inc

Los Angeles, California, United States

North Valley Hematology/Oncology Medical Group

Los Angeles, California, United States

UCLA Hematology/Oncology - Parkside

Santa Monica, California, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Lakes Research, LLC

Miami Lakes, Florida, United States

Candler Medical Oncology Practice - Statesboro

Savannah, Georgia, United States

Candler Medical Oncology Practice - Statesboro

Savannah, Georgia, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Nebraska Hematology-Oncology, P.C.

Lincoln, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Mount Sinai Cancer Center

New York, New York, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Oncology Consultants P.A.

Houston, Texas, United States

Joe Arrington Cancer Center

Lubbock, Texas, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

St Vincent's Hospital

Sydney, New South Wales, Australia

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Mater Adult Hospital Brisbane

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Barwon Health - The Geelong Hospital

Geelong, Victoria, Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia, Australia

Medizinische Universitaet Graz

Graz, Styria, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, Austria

Ordensklinikum Linz

Linz, Upper Austria, Austria

Medizinische Universität Wien

Vienna, Vienna, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Vienna, Austria

Iridium Kankernetwerk Wilrijk en Antwerp

Wilrijk, Antwerpen, Belgium

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Institut Jules Bordet

Anderlecht, Bruxelles-Capitale, Région de, Belgium

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, Belgium

AZ Delta

Roeselare, Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

Lakeridge Health

Oshawa, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Princess Margaret Hospital (Ontario)

Toronto, Ontario, Canada

Hopital Notre Dame

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

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

Montreal, Quebec, Canada

Hopital du Saint-Sacrement

Québec, Canada

Polyclinique Bordeaux Nord

Bordeaux, Aquitaine, France

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Brittany Region, France

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll

Saint-Brieuc, Côtes-d'Armor, France

Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-Roussillon, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-Atlantique, France

Polyclinique de Gentilly

Nancy, Meurthe-et-Moselle, France

CHD Vendee

La Roche-sur-Yon, Vendée, France

CHU de Besancon Hopital Jean Minjoz

Besançon, France

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Klinikum Rechts der Isar der TU München

München, Bavaria, Germany

Helios Dr. Horst Schmidt Kliniken

Wiesbaden, Hesse, Germany

Marien-Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Lübecker Onkologische Schwerpunktpraxis

Lübeck, Schleswig-Holstein, Germany

Facharztzentrum Eppendorf

Hamburg, Germany

Kath. Marienkrankenhaus gGmbH

Hamburg, Germany

Alexandra Hospital

Athens, Attikí, Greece

Rabin Medical Center

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Kaplan Medical Center

Rehovot, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Soroka Medical Center

Beersheba, Israel

Meir Medical Center

Kfar Saba, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Rambam Health Care Campus

Haifa, Ḥeifā, Israel

Ospedale Perrino

Brindisi, BR, Italy

Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, Italy

Ospedale San Martino

Genoa, Liguria, Italy

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

Candiolo, Torino, Italy

Nuovo Ospedale di Prato-S.Stefano

Prato, Tuscany, Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, Verona, Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Ospedale Bellaria - Azienda USL di Bologna

Bologna, Italy

Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

Messina, Italy

Policlinico Ospedale S. Andrea

Roma, Italy

Azienda Ospedaliera Santa Maria Terni

Terni, Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Chiba cancer center

Chiba, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Kindai University Hospital- Osakasayama Campus

Ōsaka-sayama, Osaka, Japan

Saitama Prefectural Cancer Center

Kitaadachi-Gun, Saitama, Japan

Shizuoka Cancer Center

Nakatogari, Shizuoka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

Bunkyo-ku, Tokyo, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Hiroshima City Hospital

Hiroshima, Japan

Kyoto University Hospital

Kyoto, Japan

National Hospital Organization Osaka Medical Center

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Clinica Oncológica San Francisco

Torreón, Coahuila, Mexico

Superare Centro de Infusion

México, Federal District, Mexico

Fundacion Rodolfo Padilla AC

León, Guanajuato, Mexico

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Hospital La Raza

Mexico City, Mexico City, Mexico

Grupo Medico Camino Sc

Mexico City, Mexico City, Mexico

Centro Oncologico Belenus

Cuernavaca, Morelos, Mexico

Centro de Estudios Y Prevencion Del Cancer

Juchitán de Zaragoza, Oaxaca, Mexico

Cancerología

Colinas Del Cimatario, Querétaro, Mexico

Haga Ziekenhuis locatie Leyweg

The Hague, South Holland, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Auckland City Hospital

Auckland, New Zealand

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Arkhangelskaya oblast, Russia

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

Moscow, Moscow, Russia

European Medical Center

Moscow, Russian Federation, Russia

Clinic Complex

Saint Petersburg, Russian Federation, Russia

Republic Oncology Dispensary of MoH of Republic Tatarstan

Kaznan, Russia, Russia

Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, Russia

Rosmedtech Scientific Research Institute of Oncology

Saint Petersburg, Russia

Onkologicky Ustav sv. Alzbety

Bratislava, Bratislava Region, Slovakia

Vychodoslovensky Onkologicky ustav a.s.

Košice, Košice Region, Slovakia

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Kyungpook National University Chilgok Hospital

Daegu, Taegu-Kwangyǒkshi, South Korea

Ulsan University Hospital

Ulsan, Ulsan-Kwangyǒkshi, 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, Spain

Barcelona, Spain

Donostia / San Sebastian, Spain

Lleida, Spain

Madrid, Spain

Valencia, Spain

Gävle, Sweden

Örebro, Sweden

Västerås, Sweden

Beidou, Taiwan

Kuei Shan Hsiang, Taiwan

Taichung, Taiwan

Taipei, Taiwan

Zhonghe, Taiwan

Ankara, Turkey (Türkiye)

Edirne, Turkey (Türkiye)

Malatya, Turkey (Türkiye)

Bebbington, United Kingdom

Cambridge, United Kingdom

Manchester, United Kingdom

Sutton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (155)