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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04752332
Other study ID # 17384
Secondary ID I3Y-MC-JPCW2020-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 10, 2021
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2450
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Abemaciclib
Administered orally.
Standard Adjuvant ET
Administered according to label instructions.
Placebo
Administered orally.

Locations

Country Name City State
Argentina Fundación Cenit Para La Investigación En Neurociencias Caba Ciudad Autónoma De Buenos Aires
Argentina Centro Medico Privado CEMAIC Capital Córdoba
Argentina Fundación CORI para la Investigación y Prevención del Cáncer La Rioja
Argentina Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires
Argentina Sanatorio Parque Salta
Argentina CER San Juan San Juan
Argentina Centro Medico San Roque San Miguel de Tucumán Tucumán
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Calvary Mater Newcastle Waratah New South Wales
Austria Ordensklinikum Linz Linz Oberösterreich
Austria Medizinische Universität Wien Vienna Wien
Belgium AZ Maria Middelares Gent Oost-Vlaanderen
Belgium Jan Yperman ziekenhuis Ieper West-Vlaanderen
Belgium AZ Groeninge Campus Kennedylaan Kortrijk West-Vlaanderen
Belgium Clinique Saint Pierre Ottignies Wallonne, Région
Brazil Instituto de Educação, Pesquisa e Gestão em Saúde Rio de Janeiro
Brazil Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo
Brazil Instituto de Ensino e Pesquisa São Lucas São Paulo
Brazil NotreDame Intermedica Saude S.A São Paulo
Brazil Núcleo de Pesquisa Clínica da Rede São Camilo São Paulo
China Beijing Cancer hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China Afflilated Hospital of Bengbu Medical College Bengbu Anhui
China The Second Hospital of Jilin University Changchun Jilin
China Hunan Cancer Hospital Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China West China Hospital of Sichuan University Cheng Du Sichuan
China Sichuan Cancer hospital Chengdu Sichuan
China Fujian Medical University Union Hospital-1 Bingfanglou Fuzhou Fujian Fujian
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
China Hainan Cancer Hospital Haikou Hainan
China The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang
China The First People's Hospital of Hangzhou Hangzhou Zhejiang
China LinYi Cancer Hospital Linyi Shandong
China The Third Hospital of Nanchang Nanchang Jiangxi
China Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin
China Xinjiang Medical University Cancer Hospital - Urumqi Urumqi Xinjiang
China Hubei Cancer Hospital Wuhan Hubei
China Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
France CHU Besançon Besançon Doubs
France Clinique Victor Hugo Le Mans Le Mans Pays-de-la-Loire
France Centre Oscar Lambret Lille Nord
France Institut de Cancérologie de Lorraine Alexis Vautrin Vandoeuvre-lès-Nancy Meurthe-et-Moselle
Germany Klinikum Ludwigsburg Ludwigsburg Baden-Württemberg
Germany Universitätsmedizin Mannheim Mannheim Baden-Württemberg
Germany St. Vincenz-Krankenhaus Frauen- und Kinderklinik Paderborn Nordrhein-Westfalen
Germany Universitaetsklinikum Ulm Ulm Baden-Württemberg
Greece Alexandra Hospital Athina Attikí
Greece General Oncology Hospital of Kifissia "Agioi Anargiroi" Nea Kifissia Attikí
Greece Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki
Greece European Interbalkan Medical Center Thessaloniki
Hungary Petz Aladar Egyetemi Oktato Korhaz Gyor Gyor-Moson-Sopron
Israel Sourasky Medical Center Tel Aviv Tell Abib
Italy Ospedale Mater Salutis Legnago Verona
Italy Ospedale Generale Provinciale Macerata Macerata
Italy Ospedale San Giovanni Moscati Statte Taranto
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan Chiba cancer center Chiba-shi Chiba
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Hospital Organization Kyushu Cancer Center Fukuoka
Japan Hiroshima University Hospital Hiroshima
Japan Sagara Hospital Kagoshima
Japan Ishikawa Prefectural Central Hospital Kanazawa Ishikawa
Japan St. Marianna University Hospital Kawasaki Kanagawa
Japan Japanese Foundation for Cancer Research Koto Tokyo
Japan Kumamoto Shinto General Hospital Kumamoto
Japan National Hospital Organization Shikoku Cancer Center Matsuyama Ehime
Japan Nagoya City University Hospital Nagoya Aichi
Japan National Hospital Organization Osaka Medical Center Osaka
Japan Osaka International Cancer Institute Osaka
Japan Gunma Prefectural Cancer Center Ota Gunma
Japan Showa University Hospital Shinagawa Tokyo
Japan Shizuoka General Hospital Shizuoka
Japan St. Luke's International Hospital Tokyo
Japan Tsukuba University Hospital Tsukuba Ibaraki
Korea, Republic of Inha University Hospital Incheon Incheon-gwangyeoksi [Incheon]
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam-si Kyonggi-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]
Mexico Centro Oncológico Internacional (COI) Guadalajara Jalisco
Mexico Grupo Medico Camino Sc Mexico City Distrito Federal
Spain CHUAC-Hospital Teresa Herrera A Coruña A Coruña [La Coruña]
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid Madrid, Comunidad De
Spain H.R.U Málaga - Hospital Materno-infantil Malaga Málaga
Spain Hospital Universitario de Canarias San Cristobal de La laguna Santa Cruz De Tenerife
Spain Hospital Quirónsalud Valencia Valencia
Switzerland Brustzentrum Ostschweiz St.Gallen Sankt Gallen
Switzerland Kantonsspital Winterthur Winterthur Zürich
Taiwan Koo Foundation Sun Yat-Sen Cancer Center Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan
United Kingdom Bristol Haematology and Oncology Centre Bristol Bristol, City Of
United Kingdom Royal Marsden Hospital Chelsea London
United Kingdom Colchester General Hospital Colchester Essex
United Kingdom Ipswich Hospital Ipswich Suffolk
United Kingdom Charing Cross Hospital London Hammersmith And Fulham
United Kingdom Royal Marsden Hospital (Sutton) London Sutton
United Kingdom The Christie Manchester
United States Mt. Sinai Hospital PRiSMS Chicago Illinois
United States Texas Oncology - Medical City Dallas Dallas Texas
United States Palo Verde Cancer Specialists Glendale Arizona
United States Millennium Oncology - Hollywood Hollywood Florida
United States Cornell-Beshore Cancer Institute Joplin Missouri
United States TRIO-US (Translational Research in Oncology-US) Los Angeles California
United States Sarah Cannon Research Institute SCRI Nashville Tennessee
United States The Valley Hospital Ridgewood New Jersey
United States Florida Cancer Specialists - North Saint Petersburg Florida
United States Northwest Cancer Specialists PC The Woodlands Texas
United States Texas Oncology - Medical City Dallas The Woodlands Texas
United States US Oncology The Woodlands Texas
United States USO-Southern Cancer Center, P.C. The Woodlands Texas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  China,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Invasive Disease Free Survival (IDFS) IDFS as defined by the STEEP System Randomization to Recurrence or Death from Any Cause (up to 10 Years)
Secondary Overall Survival (OS) OS Randomization to Death from Any Cause (up to 10 Years)
Secondary Distant Relapse-Free Survival (DRFS) DRFS Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence Percentage of Participants with CNS Metastases as First Site of Disease Recurrence Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score 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. Cycle 1 up to end of Year 4
Secondary Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score 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. Cycle 1 up to end of Year 4
Secondary Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib PK: Mean Steady State Concentrations of Abemaciclib Day 1 of Cycles 1-3 (Cycle = 28 days)
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