Breast Cancer Clinical Trial

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

Summary

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have confirmed HR+, HER2+ early invasive breast cancer without evidence of disease recurrence or distant metastases
Have undergone definitive surgery of the primary breast tumor(s)
Have tumor tissue from breast (preferred) or lymph node
Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
Have completed approximately nine to 20 months of standard HER2-targeted therapy (neoadjuvant/adjuvant combined duration)

Have received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:

For participants treated with neoadjuvant therapy and HER2-targeted therapy: A minimum of 4 cycles of T-DM1 in the adjuvant setting. NOTE: Participants may have received up to approximately 6 cycles of adjuvant trastuzumab prior to initiation of T-DM1. Additionally, participants may have switched to trastuzumab-based therapy (monotherapy or in combination with other HER2-targeted therapies) after 4 cycles of T-DM1
For participants who had definitive surgery prior to systemic therapy, a minimum of 4 cycles of adjuvant pertuzumab with trastuzumab.

Have high risk disease, defined by one of the following criteria:

Those who received neoadjuvant chemotherapy along with HER2-targeted treatment must have:

residual disease in at least one axillary lymph node, or
a residual tumor ≥ 5 cm, or
a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).

Those who had definitive surgery prior to systemic therapy and completed adjuvant chemotherapy along with HER2-targeted therapies (trastuzumab and pertuzumab) must have

tumor involvement in ≥4 ipsilateral axillary lymph nodes, or
tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and histological Grade 3, or
primary invasive tumor size of ≥ 5 cm on pathological evaluation.

Exclusion Criteria:

Have breast cancer with any of the following features:

Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
Pathological complete response from any prior early breast cancer treatments. Participants are required to have residual primary tumor and/or lymph node disease at the time of definitive surgery as indicated in inclusion criteria.
Inflammatory breast cancer

Have other medical conditions including:

Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS] treated by locoregional therapy alone ≥5 years ago; contralateral DCIS treated by locoregional therapy at any time)
Other cancer being treated and/or not in complete remission within the last 5 years (Exceptions: Appropriately treated non-melanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)
Females who are pregnant or lactating
History of venous thromboembolism
Other serious medical conditions

Have previously received treatment with:

Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor
Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, any investigational HER2 directed therapy, or T-DXd (DS8201) for treatment of breast cancer
Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)
Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care at study enrollment

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2450

Study ID:

NCT04752332

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 191 Locations for this study

See Locations Near You

Southern Cancer Center, P.C.
Daphne Alabama, 36526, United States
Palo Verde Cancer Specialists
Glendale Arizona, 85304, United States
St Joseph's Hospital and Medical Center
Phoenix Arizona, 85004, United States
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
St. Jude Heritage Medical Group
Fullerton California, 92835, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles California, 90095, United States
Mercy UC Davis Cancer Center
Merced California, 95340, United States
St. Joseph Hospital
Orange California, 92868, United States
California Cancer Associates in Research and Excellence
San Marcos California, 92069, United States
DignityHealth Dominican Hospital
Santa Cruz California, 95065, United States
Providence Saint John's Health Center
Santa Monica California, 90404, United States
Kaiser Foundation Research Institute
Vallejo California, 94589, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
St. Mary's Hospital & Medical Center
Grand Junction Colorado, 81501, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley Colorado, 80631, United States
South Broward Hospital District - Memorial Healthcare System
Hollywood Florida, 33021, United States
Millennium Oncology
Hollywood Florida, 33024, United States
OMNI Healthcare
Melbourne Florida, 32901, United States
Mount Sinai Cancer Center
Miami Beach Florida, 33140, United States
Ocala Oncology, P.A.
Ocala Florida, 34474, United States
Orlando Health UF Health Cancer Center
Orlando Florida, 32806, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Cleveland Clinic of Weston Florida
Weston Florida, 33331, United States
Dwight D. Eisenhower Army Medical Center, Hem/Onc Svc
Fort Gordon Georgia, 30905, United States
Cancer Trtmt Ctrs of Am, SE Reg Med Ctr., Inc.
Newnan Georgia, 30265, United States
The Queen's Medical Center
Honolulu Hawaii, 96813, United States
Mt. Sinai Hospital PRiSMS
Chicago Illinois, 60608, United States
Cancer Treatment Centers of America
Zion Illinois, 60099, United States
St. Elizabeth Medical Center
Edgewood Kentucky, 41017, United States
Northern Light Cancer Center LLC
Brewer Maine, 04412, United States
New England Cancer Specialists - Scarborough
Scarborough Maine, 04074, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Dana-Farber Cancer Institute
Milford Massachusetts, 01757, United States
Dana-Farber Cancer Institute
South Weymouth Massachusetts, 02190, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Cornell-Beshore Cancer Institute
Joplin Missouri, 64804, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Valley Health System
Paramus New Jersey, 07652, United States
Queens Hospital Center
Jamaica New York, 11432, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
OHSU Knight Cancer Institute
Portland Oregon, 97210, United States
Northwest Cancer Specialists PC
Tigard Oregon, 97223, United States
UPMC Pinnacle
Harrisburg Pennsylvania, 17109, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sarah Cannon Research Institute SCRI
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Texas Oncology - Medical City Dallas
Dallas Texas, 75230, United States
Joe Arrington Cancer Center
Lubbock Texas, 79410, United States
University of Texas Health Science Center - San Antonio
San Antonio Texas, 78229, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
US Oncology
The Woodlands Texas, 77380, United States
Inova Dwight and Martha Schar Center Institute
Fairfax Virginia, 22031, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Fundación CENIT para la Investigación en Neurociencias
Caba BA, C1125, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata Buenos Aires, B7600, Argentina
Centro Medico San Roque
San Miguel de Tucumán Tucuman, 4000, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Cordoba , X5008, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja , 5300, Argentina
Sanatorio Parque
Salta , 4400, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
San Juan , 5400, Argentina
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Cairns Base Hospital
Cairns North Queensland, 4870, Australia
The Townsville Hospital
Douglas Queensland, 4814, Australia
Mt Isa Hospital
Mount Isa Queensland, 4825, Australia
Mater Adult Hospital Brisbane
South Brisbane Queensland, 4101, Australia
Gold Coast University Hospital
Southport Queensland, 4215, Australia
Mackay Base Hospital
West Mackay Queensland, 4740, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Ordensklinikum Linz
Linz Oberösterreich, 4010, Austria
AKH
Wien , 1090, Austria
Jan Yperman Ziekenhuis
Ieper West-Vlaanderen, 8900, Belgium
AZ Maria Middelares
Gent , 9100, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
Clinique Saint Pierre Ottignies
Ottignies , 1340, Belgium
Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed
Pacaembu São Paulo, 01236, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro , 22775, Brazil
Clinica Onco Star
Sao Paulo , 04543, Brazil
Instituto de Pesquisa Notredame Intermedica
São Paulo , 01227, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo , 04014, Brazil
The First Afflilated Hospital of Bengbu Medical College
Bengbu Anhui, 23300, China
Peking University People's Hospital
Beijing Beijing, 10004, China
Beijing Cancer hospital
Beijing Beijing, 10014, China
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51008, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou Guangdong, 51008, China
Hainan Cancer Hospital
Haikou Hainan, 57031, China
Wu Han Tongji Hospital
Wu Han Hu Bei, 43003, China
Tongji Medical College of Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
Xiangya Hospital Central South University
Changsha Hunan, 41000, China
Hunan Cancer Hospital
Changsha Hunan, 41001, China
Jilin Cancer Hospital
Chang Chun Ji Lin, 13001, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing Jiangsu, 21000, China
The Third Hospital of Nanchang
Nanchang Jiangxi, 33000, China
The Second Hospital of Jilin University
Changchun Jilin, 13000, China
Linyi Cancer Hospital
Linyi Shandong, 27600, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20003, China
West China Hospital of Sichuan University
Chengdu Sichuan, 61004, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, , China
Xinjiang Medical University Cancer Hospital
Urumqi Xinjiang, 83000, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou Zhejiang, 31000, China
The First People's Hospital of Hangzhou
Hangzhou Zhejiang, 31000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Sichuan Cancer Hospital
Chengdu , 61004, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'An , 71006, China
Kuopio University Hospital
Kuopio , 70210, Finland
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandoeuvre-lès-Nancy Lorraine, 54519, France
Centre Oscar Lambret
Lille Nord, 59020, France
CHU de Besancon Hopital Jean Minjoz
Besancon Cedex , 25030, France
Centre François Baclesse
Caen , 14000, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans , 72000, France
Centre Leon Berard
Lyon Cedex 08 , 69373, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
Rennes Cedex , 35042, France
Klinikum Ludwigsburg
Ludwigsburg Baden-Württemberg, 71640, Germany
Klinikum Mannheim gGmbH Universitätsmedizin
Mannheim Baden-Württemberg, 68167, Germany
Universitätsklinikum Ulm
Ulm Baden-Württemberg, 89075, Germany
Klinikum Rechts der Isar der TU München
München Bayern, 81675, Germany
Universitätsklinikum Düsseldorf
Düsseldorf Nordrhein-Westfalen, 40225, Germany
Universitätsklinikum Halle
Halle Sachsen-Anhalt, 06120, Germany
Universitaetsklinikum Augsburg
Augsburg , 86156, Germany
ÜBAG-Med. Versorgungszentrum - VK&K Studien GbR
Landshut , 84036, Germany
St. Vincenz-Krankenhaus Frauen- und Kinderklinik
Paderborn , 33098, Germany
Alexandra General Hospital of Athens
Athens Attikí, 11528, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia Attikí, 14564, Greece
General Hospital of Thessaloniki Papageorgiou
N. Efkarpia Thessaloniki, 56403, Greece
European Interbalkan Medical Center
Thessaloniki Thessaloníki, 570 0, Greece
Euromedica - General Clinic of Thessaloniki
Thessaloniki , 54645, Greece
Petz Aladar Egyetemi Oktato Korhaz
Gyor , 9023, Hungary
Tel Aviv Sourasky Medical Center
Tel Aviv Jaffa , 64239, Israel
Policlinico Gemelli - Università Cattolica del Sacro Cuore
Roma Lazio, 00168, Italy
Istituto Oncologico Veneto IRCCS
Padova Veneto, 35128, Italy
Ospedale Mater Salutis
Legnago Verona, 37045, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
IRCCS Ospedale Policlinico San Martino
Genova , 16132, Italy
Ospedale Generale Provinciale Macerata
Macerata , 62100, Italy
Ospedale S.G. Moscati
Taranto , 74010, Italy
Nagoya University Hospital
Nagoya Aichi, 466-8, Japan
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan
Chiba cancer center
Chiba-shi Chiba, 260-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
Gunma Prefectural Cancer Center
Ota Gunma, 373-0, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo Hokkaido, 003-0, Japan
University of tsukuba hospital
Tsukuba-shi Ibaragi, 305-8, Japan
Ishikawa Prefectural Central Hospital
Kanazawa Ishikawa, 920-8, Japan
St. Marianna University Hospital
Kawasaki Kanagawa, 216-8, Japan
Niigata Cancer Center Hospital
Niigata-shi Niigata, 951-8, Japan
Juntendo University Hospital
Bunkyo-ku Tokyo, 113-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Japanese Foundation for Cancer Research
Koto Tokyo, 135-8, Japan
Showa University Hospital
Shinagawa Tokyo, 142-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
Sagara Hospital
Kagoshima , 892-0, Japan
Kumamoto Shinto General Hospital
Kumamoto , 862-8, Japan
National Hospital Organization Osaka National Hospital
Osaka , 540-0, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Shizuoka Prefectural General Hospital
Shizuoka , 420-0, Japan
St. Luke's International Hospital
Tokyo , 104-8, Japan
CHA Bundang Medical Center, CHA University
Sungnam-si Gyeonggi-do, 13496, Korea, Republic of
Inha University Hospital
Incheon Incheon-gwangyeoksi [Incheon], 22332, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam Kyǒnggi-do, 13620, Korea, Republic of
Korea University Anam Hospital
Seoul Seoul-teukbyeolsi [Seoul], 02841, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Grupo Médico Camino SC Oncología
Mexico City MX, 03310, Mexico
COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F.
Paso De Las Lomas MX, 01330, Mexico
The American British Cowdray Hospital
Mexico City , 01120, Mexico
University Of Puerto Rico
San Juan , 00935, Puerto Rico
Hospital Universitari Arnau de Vilanova
Lleida Cataluña, 25198, Spain
Hospital del Mar
Barcelona , 08003, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruña , 15006, Spain
Hospital Universitario de Canarias
La Laguna , , Spain
Hospital La Princesa
Madrid , 28006, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Regional Universitario
Málaga , 29010, Spain
Hospital Quirón Salud Valencia
Valencia , 46010, Spain
Karolinska Universitetssjukhuset i Solna
Solna , 17176, Sweden
Inselspital Bern
Bern , 3010, Switzerland
Brustzentrum Ostschweiz
St. Gallen , 9016, Switzerland
Kantonsspital Winterthur
Winterthur , 8401, Switzerland
National Taiwan University Hospital
Taipei , 10002, Taiwan
Koo Foundation Sun Yan-Sen Cancer Center
Taipei , 11259, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan City , 333, Taiwan
Colchester General Hospital
Colchester Essex, CO4 5, United Kingdom
North Middlesex Hospital
London Greater London, N18 1, United Kingdom
The Christie NHS Foundation Trust
Manchester Greater Manchester, M20 4, United Kingdom
Charing Cross Hospital
London Hammersmith And Fulham, W6 8R, United Kingdom
Royal Marsden Hospital
Chelsea London, SW3 6, United Kingdom
The Clatterbridge Cancer Centre
Bebbington Merseyside, CH63 , United Kingdom
Western General Hospital
Edinburgh Scotland, EH4 2, United Kingdom
Weston Park Hospital
Sheffield South Yorkshire, S10 2, United Kingdom
Ipswich Hospital
Ipswich Suffolk, IP4 5, United Kingdom
Royal Marsden NHS Trust
Sutton Surrey, SM2 5, United Kingdom
Freeman Hospital
Newcastle Upon Tyne Tyne And Wear, NE7 2, United Kingdom
Queen Elizabeth Hospital
Birmingham West Midlands, B15 2, United Kingdom
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
Guys/St. Thomas Hospital
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2450

Study ID:

NCT04752332

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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