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

NCT ID: NCT04752332

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2024-06-26

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

150 mg Abemaciclib + Endocrine Therapy (ET)

Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).

Group Type: EXPERIMENTAL

Abemaciclib

Intervention Type: DRUG

Administered orally.

Standard Adjuvant ET

Intervention Type: DRUG

Administered according to label instructions.

Placebo + ET

Participants received placebo administered BID orally along with standard adjuvant ET.

Group Type: ACTIVE_COMPARATOR

Standard Adjuvant ET

Intervention Type: DRUG

Administered according to label instructions.

Placebo

Intervention Type: DRUG

Administered orally.

Interventions

Abemaciclib

Administered orally.

Intervention Type: DRUG

Standard Adjuvant ET

Administered according to label instructions.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Other Intervention Names

LY2835219

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.

• 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

Exclusion Criteria

• Have breast cancer with any of the following features:

• Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Palo Verde Cancer Specialists

Glendale, Arizona, United States

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, United States

Millennium Oncology - Hollywood

Hollywood, Florida, United States

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Mt. Sinai Hospital PRiSMS

Chicago, Illinois, United States

Cornell-Beshore Cancer Institute

Joplin, Missouri, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, United States

Texas Oncology - Medical City Dallas

Dallas, Texas, 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, United States

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, , Argentina

Sanatorio Parque

Salta, , Argentina

CER San Juan

San Juan, , Argentina

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Ordensklinikum Linz

Linz, Upper Austria, Austria

Medizinische Universität Wien

Vienna, Vienna, Austria

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

Clinique Saint Pierre

Ottignies, Wallonne, Région, Belgium

Jan Yperman ziekenhuis

Ieper, West-Vlaanderen, Belgium

AZ Groeninge Campus Kennedylaan

Kortrijk, West-Vlaanderen, Belgium

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, , Brazil

NotreDame Intermedica Saude S.A

São Paulo, , Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo

São Paulo, , Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, , Brazil

Instituto de Ensino e Pesquisa São Lucas

São Paulo, , Brazil

Afflilated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Cancer hospital

Beijing, Beijing Municipality, 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

Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The Third Hospital of Nanchang

Nanchang, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jilin, China

LinYi Cancer Hospital

Linyi, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sichuan Cancer hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Cancer Hospital - Urumqi

Ürümqi, Xinjiang, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

CHU Besançon

Besançon, Doubs, France

Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Centre Oscar Lambret

Lille, Nord, France

Clinique Victor Hugo Le Mans

Le Mans, Pays de la Loire Region, France

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

St. Vincenz-Krankenhaus Frauen- und Kinderklinik

Paderborn, North Rhine-Westphalia, Germany

Alexandra Hospital

Athens, 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, , Greece

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel

Ospedale San Giovanni Moscati

Statte, Taranto, Italy

Ospedale Mater Salutis

Legnago, Verona, Italy

Ospedale Generale Provinciale Macerata

Macerata, , Italy

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Chiba cancer center

Chiba, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

Showa University Hospital

Shinagawa, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Hiroshima University Hospital

Hiroshima, , Japan

Sagara Hospital

Kagoshima, , Japan

Kumamoto Shinto General Hospital

Kumamoto, , Japan

National Hospital Organization Osaka Medical Center

Osaka, , Japan

Osaka International Cancer Institute

Osaka, , Japan

Shizuoka General Hospital

Shizuoka, , Japan

St. Luke's International Hospital

Tokyo, , Japan

Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, Mexico

Grupo Medico Camino Sc

Mexico City, Mexico City, Mexico

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, Kyǒnggi-do, South Korea

Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

CHUAC-Hospital Teresa Herrera

A Coruña, A Coruña [La Coruña], Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

H.R.U Málaga - Hospital Materno-infantil

Málaga, Málaga, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Quirónsalud Valencia

Valencia, , Spain

Brustzentrum Ostschweiz

Sankt Gallen, Canton of St. Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

National Taiwan University Hospital

Taipei, , Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, , Taiwan

Bristol Haematology and Oncology Centre

Bristol, Bristol, City of, United Kingdom

Colchester General Hospital

Colchester, Essex, United Kingdom

Charing Cross Hospital

London, Hammersmith and Fulham, United Kingdom

Royal Marsden Hospital

Chelsea, London, United Kingdom

Ipswich Hospital

Ipswich, Suffolk, United Kingdom

Royal Marsden Hospital (Sutton)

London, Sutton, United Kingdom

The Christie

Manchester, , United Kingdom

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/5KSTmaOP3TBgL5LfSMwHYU

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

Other Identifiers

I3Y-MC-JPCW

Identifier Type: OTHER

Identifier Source: secondary_id

2020-004035-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17384

Identifier Type: -

Identifier Source: org_study_id