A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT04752332
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 111
-
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.
-
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abemaciclib Plus (+) Endocrine Therapy (ET) Standard Adjuvant ET Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label. Placebo + ET Standard Adjuvant ET Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label. Placebo + ET Placebo Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label. Abemaciclib Plus (+) Endocrine Therapy (ET) Abemaciclib Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
- Primary Outcome Measures
Name Time Method Invasive Disease Free Survival (IDFS) Randomization to Recurrence or Death from Any Cause (up to 10 Years) IDFS as defined by the STEEP System
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Randomization to Death from Any Cause (up to 10 Years) OS
Distant Relapse-Free Survival (DRFS) Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) DRFS
Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) Percentage of Participants with CNS Metastases as First Site of Disease Recurrence
Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score Cycle 1 up to end of Year 4 EORTC QLQ-C30 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score Cycle 1 up to end of Year 4 The EQ-5D is a self-administered questionnaire that participants complete to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 5 (no problem, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively). These combinations of attributes were converted into a weighted Health State Index score; the possible values for the Health State Index score range from less than 0 (0 equals health state of "dead"; severe problems in all 5 dimensions) to 1.0 (full health; no problem in any dimension). Higher score indicates better health state.
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib Day 1 of Cycles 1-3 (Cycle = 28 days) PK: Mean Steady State Concentrations of Abemaciclib
Trial Locations
- Locations (114)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Hainan Cancer Hospital
🇨🇳Haikou, Hainan, China
Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Cheng Du, Sichuan, China
Ipswich Hospital
🇬🇧Ipswich, Suffolk, United Kingdom
Institut de Cancérologie de Lorraine Alexis Vautrin
🇫🇷Vandoeuvre-lès-Nancy, Meurthe-et-Moselle, France
Colchester General Hospital
🇬🇧Colchester, Essex, United Kingdom
Florida Cancer Specialists - North
🇺🇸Saint Petersburg, Florida, United States
Centro Medico San Roque
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
Centro Medico Privado CEMAIC
🇦🇷Capital, Córdoba, Argentina
Sanatorio Parque
🇦🇷Salta, Argentina
Ordensklinikum Linz
🇦🇹Linz, Oberösterreich, Austria
CER San Juan
🇦🇷San Juan, Argentina
Núcleo de Pesquisa Clínica da Rede São Camilo
🇧🇷São Paulo, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
🇧🇷Rio de Janeiro, Brazil
Afflilated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Instituto de Ensino e Pesquisa São Lucas
🇧🇷São Paulo, Brazil
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital-1 Bingfanglou
🇨🇳Fuzhou Fujian, Fujian, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Xinjiang Medical University Cancer Hospital - Urumqi
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
St. Vincenz-Krankenhaus Frauen- und Kinderklinik
🇩🇪Paderborn, Nordrhein-Westfalen, Germany
General Oncology Hospital of Kifissia "Agioi Anargiroi"
🇬🇷Nea Kifissia, Attikí, Greece
European Interbalkan Medical Center
🇬🇷Thessaloniki, Greece
Petz Aladar Egyetemi Oktato Korhaz
🇭🇺Gyor, Győr-Moson-Sopron, Hungary
Ospedale San Giovanni Moscati
🇮🇹Statte, Taranto, Italy
Ospedale Mater Salutis
🇮🇹Legnago, Verona, Italy
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Ospedale Generale Provinciale Macerata
🇮🇹Macerata, Italy
Chiba cancer center
🇯🇵Chiba-shi, Chiba, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota, Gunma, Japan
Tsukuba University Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Showa University Hospital
🇯🇵Shinagawa, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Sagara Hospital
🇯🇵Kagoshima, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Kumamoto Shinto General Hospital
🇯🇵Kumamoto, Japan
National Hospital Organization Osaka Medical Center
🇯🇵Osaka, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
CHUAC-Hospital Teresa Herrera
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Centro Oncológico Internacional (COI)
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Universitario de Canarias
🇪🇸San Cristobal de La laguna, Santa Cruz De Tenerife, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Quirónsalud Valencia
🇪🇸Valencia, Spain
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Bristol Haematology and Oncology Centre
🇬🇧Bristol, Bristol, City Of, United Kingdom
Royal Marsden Hospital
🇬🇧Chelsea, London, United Kingdom
Palo Verde Cancer Specialists
🇺🇸Glendale, Arizona, United States
Fundación Cenit Para La Investigación En Neurociencias
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
🇦🇷La Rioja, Argentina
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Jan Yperman ziekenhuis
🇧🇪Ieper, West-Vlaanderen, Belgium
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
AZ Maria Middelares
🇧🇪Gent, Oost-Vlaanderen, Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR)
🇧🇷São Paulo, Brazil
NotreDame Intermedica Saude S.A
🇧🇷São Paulo, Brazil
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
Sichuan Cancer hospital
🇨🇳Chengdu, Sichuan, China
LinYi Cancer Hospital
🇨🇳Linyi, Shandong, China
CHU Besançon
🇫🇷Besançon, Doubs, France
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Baden-Württemberg, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Baden-Württemberg, Germany
Alexandra Hospital
🇬🇷Athina, Attikí, Greece
Euromedica General Clinic of Thessaloniki
🇬🇷Thessaloniki, Thessaloníki, Greece
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
St. Marianna University Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Shizuoka General Hospital
🇯🇵Shizuoka, Japan
Inha University Hospital
🇰🇷Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Grupo Medico Camino Sc
🇲🇽Mexico City, Distrito Federal, Mexico
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Kyǒnggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Madrid, Comunidad De, Spain
H.R.U Málaga - Hospital Materno-infantil
🇪🇸Malaga, Málaga, Spain
Brustzentrum Ostschweiz
🇨🇭St.Gallen, Sankt Gallen, Switzerland
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
The Christie
🇬🇧Manchester, United Kingdom
Royal Marsden Hospital (Sutton)
🇬🇧London, Sutton, United Kingdom
Centre Oscar Lambret
🇫🇷Lille, Nord, France
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Medizinische Universität Wien
🇦🇹Vienna, Wien, Austria
Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
Kantonsspital Winterthur
🇨🇭Winterthur, Zürich, Switzerland
Clinique Victor Hugo Le Mans
🇫🇷Le Mans, Pays-de-la-Loire, France
TRIO-US (Translational Research in Oncology-US)
🇺🇸Los Angeles, California, United States
Cornell-Beshore Cancer Institute
🇺🇸Joplin, Missouri, United States
Millennium Oncology - Hollywood
🇺🇸Hollywood, Florida, United States
Mt. Sinai Hospital PRiSMS
🇺🇸Chicago, Illinois, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
US Oncology
🇺🇸The Woodlands, Texas, United States
Sarah Cannon Research Institute SCRI
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Medical City Dallas
🇺🇸The Woodlands, Texas, United States
Northwest Cancer Specialists PC
🇺🇸The Woodlands, Texas, United States
USO-Southern Cancer Center, P.C.
🇺🇸The Woodlands, Texas, United States
Clinique Saint Pierre
🇧🇪Ottignies, Wallonne, Région, Belgium
AZ Groeninge Campus Kennedylaan
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Charing Cross Hospital
🇬🇧London, Hammersmith And Fulham, United Kingdom