Clinical trial NCT04752332: A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Official title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Invasive Disease Free Survival (IDFS)
timeFrame: Randomization to Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to Death from Any Cause (up to 10 Years)
measure: Distant Relapse-Free Survival (DRFS)
timeFrame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
measure: Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence
timeFrame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
measure: Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
timeFrame: Cycle 1 up to end of Year 4
measure: Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
timeFrame: Cycle 1 up to end of Year 4
measure: Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
timeFrame: Day 1 of Cycles 1-3 (Cycle = 28 days)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Palo Verde Cancer Specialists
state: Arizona
city: Los Angeles
country: United States
facility: TRIO-US (Translational Research in Oncology-US)
state: California
city: Hollywood
country: United States
facility: Millennium Oncology - Hollywood
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North
state: Florida
city: Chicago
country: United States
facility: Mt. Sinai Hospital PRiSMS
state: Illinois
city: Joplin
country: United States
facility: Cornell-Beshore Cancer Institute
state: Missouri
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: The Woodlands
country: United States
facility: Northwest Cancer Specialists PC
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: The Woodlands
country: United States
facility: USO-Southern Cancer Center, P.C.
state: Texas
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: Caba
country: Argentina
facility: Fundación Cenit Para La Investigación En Neurociencias
state: Ciudad Autónoma De Buenos Aires
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC
state: Córdoba
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico San Roque
state: Tucumán
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer
city: Salta
country: Argentina
facility: Sanatorio Parque
city: San Juan
country: Argentina
facility: CER San Juan
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Oberösterreich
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
state: Wallonne, Région
city: Ieper
country: Belgium
facility: Jan Yperman ziekenhuis
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
state: West-Vlaanderen
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educação, Pesquisa e Gestão em Saúde
city: São Paulo
country: Brazil
facility: NotreDame Intermedica Saude S.A
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo
city: São Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
city: São Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas
city: Bengbu
country: China
facility: Afflilated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Fuzhou Fujian
country: China
facility: Fujian Medical University Union Hospital-1 Bingfanglou
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Haikou
country: China
facility: Hainan Cancer Hospital
state: Hainan
city: Wuhan
country: China
facility: Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Linyi
country: China
facility: LinYi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
city: Besançon
country: France
facility: CHU Besançon
state: Doubs
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine Alexis Vautrin
state: Meurthe-et-Moselle
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Pays-de-la-Loire
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-Württemberg
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus Frauen- und Kinderklinik
state: Nordrhein-Westfalen
city: Athina
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Nea Kifissia
country: Greece
facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"
state: Attikí
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz
state: Győr-Moson-Sopron
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Statte
country: Italy
facility: Ospedale San Giovanni Moscati
state: Taranto
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
state: Verona
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale Macerata
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba cancer center
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima
country: Japan
facility: Sagara Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Mexico City
country: Mexico
facility: Grupo Medico Camino Sc
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Oncológico Internacional (COI)
state: Jalisco
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera
state: A Coruña [La Coruña]
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Malaga
country: Spain
facility: H.R.U Málaga - Hospital Materno-infantil
state: Málaga
city: San Cristobal de La laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital Quirónsalud Valencia
city: St.Gallen
country: Switzerland
facility: Brustzentrum Ostschweiz
state: Sankt Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zürich
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: Bristol, City Of
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: Essex
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: Hammersmith And Fulham
city: Chelsea
country: United Kingdom
facility: Royal Marsden Hospital
state: London
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: Suffolk
city: London
country: United Kingdom
facility: Royal Marsden Hospital (Sutton)
state: Sutton
city: Manchester
country: United Kingdom
facility: The Christie
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: