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.
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
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There are 191 Locations for this study
Daphne Alabama, 36526, United States
Glendale Arizona, 85304, United States
Phoenix Arizona, 85004, United States
Beverly Hills California, 90211, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Merced California, 95340, United States
Orange California, 92868, United States
San Marcos California, 92069, United States
Santa Cruz California, 95065, United States
Santa Monica California, 90404, United States
Vallejo California, 94589, United States
Aurora Colorado, 80045, United States
Grand Junction Colorado, 81501, United States
Greeley Colorado, 80631, United States
Hollywood Florida, 33021, United States
Hollywood Florida, 33024, United States
Melbourne Florida, 32901, United States
Miami Beach Florida, 33140, United States
Ocala Florida, 34474, United States
Orlando Florida, 32806, United States
Saint Petersburg Florida, 33705, United States
Weston Florida, 33331, United States
Fort Gordon Georgia, 30905, United States
Newnan Georgia, 30265, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60608, United States
Zion Illinois, 60099, United States
Edgewood Kentucky, 41017, United States
Brewer Maine, 04412, United States
Scarborough Maine, 04074, United States
Bethesda Maryland, 20889, United States
Milford Massachusetts, 01757, United States
South Weymouth Massachusetts, 02190, United States
Detroit Michigan, 48202, United States
Joplin Missouri, 64804, United States
Omaha Nebraska, 68198, United States
Paramus New Jersey, 07652, United States
Jamaica New York, 11432, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97210, United States
Tigard Oregon, 97223, United States
Harrisburg Pennsylvania, 17109, United States
Philadelphia Pennsylvania, 19107, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
The Woodlands Texas, 77380, United States
Fairfax Virginia, 22031, United States
Fort Belvoir Virginia, 22060, United States
Seattle Washington, 98109, United States
Caba BA, C1125, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
San Miguel de Tucumán Tucuman, 4000, Argentina
Cordoba , X5008, Argentina
La Rioja , 5300, Argentina
Salta , 4400, Argentina
San Juan , 5400, Argentina
Waratah New South Wales, 2298, Australia
Cairns North Queensland, 4870, Australia
Douglas Queensland, 4814, Australia
Mount Isa Queensland, 4825, Australia
South Brisbane Queensland, 4101, Australia
Southport Queensland, 4215, Australia
West Mackay Queensland, 4740, Australia
Melbourne Victoria, 3000, Australia
Linz Oberösterreich, 4010, Austria
Wien , 1090, Austria
Ieper West-Vlaanderen, 8900, Belgium
Gent , 9100, Belgium
Kortrijk , 8500, Belgium
Ottignies , 1340, Belgium
Pacaembu São Paulo, 01236, Brazil
Rio de Janeiro , 22775, Brazil
Sao Paulo , 04543, Brazil
São Paulo , 01227, Brazil
São Paulo , 04014, Brazil
Bengbu Anhui, 23300, China
Beijing Beijing, 10004, China
Beijing Beijing, 10014, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51008, China
Haikou Hainan, 57031, China
Wu Han Hu Bei, 43003, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Chang Chun Ji Lin, 13001, China
Nanjing Jiangsu, 21000, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13000, China
Linyi Shandong, 27600, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, , China
Urumqi Xinjiang, 83000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31000, China
Chengdu , 61004, China
Xi'An , 71006, China
Kuopio , 70210, Finland
Vandoeuvre-lès-Nancy Lorraine, 54519, France
Lille Nord, 59020, France
Besancon Cedex , 25030, France
Caen , 14000, France
Le Mans , 72000, France
Lyon Cedex 08 , 69373, France
Rennes Cedex , 35042, France
Ludwigsburg Baden-Württemberg, 71640, Germany
Mannheim Baden-Württemberg, 68167, Germany
Ulm Baden-Württemberg, 89075, Germany
München Bayern, 81675, Germany
Düsseldorf Nordrhein-Westfalen, 40225, Germany
Halle Sachsen-Anhalt, 06120, Germany
Augsburg , 86156, Germany
Landshut , 84036, Germany
Paderborn , 33098, Germany
Athens AttikÃ, 11528, Greece
Nea Kifissia AttikÃ, 14564, Greece
N. Efkarpia Thessaloniki, 56403, Greece
Thessaloniki ThessalonÃki, 570 0, Greece
Thessaloniki , 54645, Greece
Gyor , 9023, Hungary
Tel Aviv Jaffa , 64239, Israel
Roma Lazio, 00168, Italy
Padova Veneto, 35128, Italy
Legnago Verona, 37045, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Macerata , 62100, Italy
Taranto , 74010, Italy
Nagoya Aichi, 466-8, Japan
Nagoya Aichi, 467-8, Japan
Chiba-shi Chiba, 260-8, Japan
Matsuyama Ehime, 791-0, Japan
Ota Gunma, 373-0, Japan
Sapporo Hokkaido, 003-0, Japan
Tsukuba-shi Ibaragi, 305-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Kawasaki Kanagawa, 216-8, Japan
Niigata-shi Niigata, 951-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto Tokyo, 135-8, Japan
Shinagawa Tokyo, 142-8, Japan
Fukuoka , 811-1, Japan
Hiroshima , 734-8, Japan
Kagoshima , 892-0, Japan
Kumamoto , 862-8, Japan
Osaka , 540-0, Japan
Osaka , 541-8, Japan
Shizuoka , 420-0, Japan
Tokyo , 104-8, Japan
Sungnam-si Gyeonggi-do, 13496, Korea, Republic of
Incheon Incheon-gwangyeoksi [Incheon], 22332, Korea, Republic of
Seongnam KyÇ’nggi-do, 13620, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
Mexico City MX, 03310, Mexico
Paso De Las Lomas MX, 01330, Mexico
Mexico City , 01120, Mexico
San Juan , 00935, Puerto Rico
Lleida Cataluña, 25198, Spain
Barcelona , 08003, Spain
La Coruña , 15006, Spain
La Laguna , , Spain
Madrid , 28006, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Valencia , 46010, Spain
Solna , 17176, Sweden
Bern , 3010, Switzerland
St. Gallen , 9016, Switzerland
Winterthur , 8401, Switzerland
Taipei , 10002, Taiwan
Taipei , 11259, Taiwan
Taoyuan City , 333, Taiwan
Colchester Essex, CO4 5, United Kingdom
London Greater London, N18 1, United Kingdom
Manchester Greater Manchester, M20 4, United Kingdom
London Hammersmith And Fulham, W6 8R, United Kingdom
Chelsea London, SW3 6, United Kingdom
Bebbington Merseyside, CH63 , United Kingdom
Edinburgh Scotland, EH4 2, United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
Ipswich Suffolk, IP4 5, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Newcastle Upon Tyne Tyne And Wear, NE7 2, United Kingdom
Birmingham West Midlands, B15 2, United Kingdom
Bristol , BS2 8, United Kingdom
London , SE1 9, United Kingdom
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