Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

493

Study ID:

NCT02246621

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 166 Locations for this study

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Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States
Arizona Oncology Associates, PC - CASA
Tucson Arizona, 85715, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
California Cancer Associates Research and Excellence (cCARE)
Fresno California, 93720, United States
St. Joseph Heritage Medical Group
Fullerton California, 92835, United States
UCLA Medical Center
Los Angeles California, 90024, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles California, 90095, United States
North Valley Hematology/Oncology Medical Group
Northridge California, 91328, United States
Central Coast Medical Oncology Corporation
Santa Monica California, 93454, United States
Catholic Health Initiatives (CHI)
Englewood Colorado, 80112, United States
St Mary's Hospital Regional Cancer Center
Grand Junction Colorado, 81501, United States
Holy Cross Hospital Inc.
Fort Lauderdale Florida, 33308, United States
Lakeland Regional Cancer Center
Lakeland Florida, 33805, United States
Lakes Research LLC
Miami Lakes Florida, 33104, United States
Moroose, Reynolds and Castillo
Orlando Florida, 32804, United States
Georgia Regents University
Augusta Georgia, 30912, United States
Summit Cancer Care
Savannah Georgia, 31404, United States
Franciscan St. Francis Health
Indianapolis Indiana, 46237, United States
IU Health Ball Memorial Hospital
Muncie Indiana, 47303, United States
Office: Dr Jayne S Gurtler
Metairie Louisiana, 70006, United States
Walter Reed National Military Medical Center IRB
Bethesda Maryland, 20889, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
St. Francis Medical Center
Grand Island Nebraska, 68802, United States
Nebraska Hematology-Oncology
Lincoln Nebraska, 68506, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Broome Oncology
Johnson City New York, 13790, United States
Beth Israel Medical Center
New York New York, 10011, United States
Mid Ohio Oncology Hematology
Columbus Ohio, 43219, United States
Kaiser Permanente / Central Interstate Medical Office
Portland Oregon, 97227, United States
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
Oncology Consultants Cancer Center
Houston Texas, 77030, United States
Joe Arrington Cancer Center
Lubbock Texas, 79410, United States
Scott & White Healthcare
Round Rock Texas, 78665, United States
Scott & White Memorial Hosptial & Clinic
Temple Texas, 76508, United States
Cancer Care Northwest
Valley Washington, 99216, United States
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.
Camperdown , 2050, Australia
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Fitzroy , 3065, Australia
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Geelong , 3220, Australia
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Murdoch , 6150, Australia
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South Brisbane , 4101, Australia
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Wahroonga , 2076, Australia
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Wollongong , 2500, Australia
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Woodville , 5011, Australia
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Woolloongabba , 4102, Australia
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Innsbruck , 6020, Austria
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Linz , 4010, Austria
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Wien , 1090, Austria
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Brussels , 1200, Belgium
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Charleroi , 6000, Belgium
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Namur , 5000, Belgium
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Roeselare , 8800, Belgium
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Wilrijk , 2610, Belgium
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Edmonton Alberta, T6G 1, Canada
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Oshawa Ontario, L1G 2, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H3T 1, Canada
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Quebec , G1S 4, Canada
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Bordeaux , 33077, France
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Brest , 29609, France
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Dijon , 21034, France
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La Roche Sur Yon , 85925, France
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Lyon , 69373, France
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Montpellier , 34070, France
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Saint Herblain Cedex , 44805, France
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Saint-Brieuc , 22027, France
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Aachen , 52074, Germany
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Düsseldorf , 40479, Germany
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Hamburg , 20249, Germany
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Lubeck , 23562, Germany
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Ludwigsburg , 71640, Germany
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Munich , 81675, Germany
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München , 81675, Germany
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Ulm , 89075, Germany
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Wiesbaden , 65199, Germany
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Athens , 11528, Greece
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Heraklion , 71110, Greece
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Beer Sheva , 84101, Israel
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Haifa , 35254, Israel
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Jerusalem , 91120, Israel
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Kfar Saba , 44281, Israel
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Petah Tiqva , 49100, Israel
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Ramat Gan , 52662, Israel
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Rehovot , 76100, Israel
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Tel Aviv Jaffa , 64239, Israel
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Bergamo , 24127, Italy
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Bologna , 40139, Italy
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Brindisi , 72100, Italy
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Candiolo , 10060, Italy
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Cona , 44124, Italy
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Genova , 16132, Italy
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Messina , 98158, Italy
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Negrar , 37024, Italy
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Prato , 59100, Italy
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Rome , 00189, Italy
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Terni , 05100, Italy
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Aichi , 464-8, Japan
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Chiba , 260-8, Japan
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Ehime , 791-0, Japan
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Fukuoka , 811-1, Japan
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Hiroshima , 730-8, Japan
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Hokkaido , 003-0, Japan
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Hyogo , 663-8, Japan
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Kagoshima , 892-0, Japan
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Kanagawa , 241-0, Japan
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Kyoto , 606-8, Japan
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Niigata , 951-8, Japan
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Osaka , 540-0, Japan
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Saitama , 362-0, Japan
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Shinjuku-ku , 160-0, Japan
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Shizuoka , 411-8, Japan
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Tochigi , 329- , Japan
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Tokyo , 135-8, Japan
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Daegu , 700-7, Korea, Republic of
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Goyang-Si , 411-7, Korea, Republic of
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Gyeonggi-do , 463-0, Korea, Republic of
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Incheon , 400-7, Korea, Republic of
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Seoul , 110-7, Korea, Republic of
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Ulsan-si , 682-7, Korea, Republic of
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Cuernavaca , 62290, Mexico
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Guadalajara , 44200, Mexico
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Juchitan , 70000, Mexico
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Leon , 37000, Mexico
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Mexico City , 03310, Mexico
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Queretaro , 04200, Mexico
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Torreon , 27000, Mexico
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Den Haag , 2545 , Netherlands
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Eindhoven , 5631 , Netherlands
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Leiden , 2333 , Netherlands
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Rotterdam , 3083 , Netherlands
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Auckland , 1023, New Zealand
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Wellington , 6021, New Zealand
San Juan Ccop
San Juan , 00935, Puerto Rico
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Arkhangelsk , 16304, Russian Federation
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Kaznan , 42002, Russian Federation
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Moscow , 12909, Russian Federation
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Saint-Petersburg , 19001, Russian Federation
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Volzhskiy , 40413, Russian Federation
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Bratislava , 812 5, Slovakia
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Kosice , 041-9, Slovakia
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Badajoz , 06080, Spain
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Barcelona , 08907, Spain
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Lleida , 25198, Spain
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Madrid , 28007, Spain
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San Sebastian , 20014, Spain
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Valencia , 46015, Spain
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Gavle , 80187, Sweden
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Orebro , 70185, Sweden
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Vasteras , SE-72, Sweden
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Jhonghe City , 235, Taiwan
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Kuei Shan Hsiang , 33305, Taiwan
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Pei-Tou , 112, Taiwan
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Taichung , 40447, Taiwan
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Taipei , 100, Taiwan
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Ankara , 06100, Turkey
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Edirne , 22770, Turkey
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Istanbul , 34098, Turkey
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Kayseri , 38039, Turkey
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Malatya , 44280, Turkey
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Bebbington , CH63 , United Kingdom
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Cambridge , CB20Q, United Kingdom
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London , SE1 9, United Kingdom
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Maidstone , ME16 , United Kingdom
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Manchester , M20 4, United Kingdom
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Nottingham , NG5 1, United Kingdom
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Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

493

Study ID:

NCT02246621

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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