A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer | NCT02246621 | Trialant

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer | NCT02246621 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

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 Universität Wien

Vienna, State of Vienna 1090, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, State of Vienna 1090, Austria

Medizinische Universitaet Graz

Graz, Styria 8036, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol 6020, Austria

Ordensklinikum Linz

Linz, Upper Austria 4020, 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