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

Breast Neoplasms Clinical Trial

— eMonarcHER  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms

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)

External Links

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