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

NCT04752332 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: 17384I3Y-MC-JPCW2020-004035-24
• Study Type: interventional
• Target: 111
• Locations: 19 countries
• Sites: 113

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

Outcome Measures

Primary Outcomes (1)

• Invasive Disease Free Survival (IDFS)

  IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

  Randomization to Recurrence or Death from Any Cause (up to 890 days)

Secondary Outcomes (6)

• Overall Survival (OS)

  Randomization to Death from Any Cause (up to 890 days)

• Distant Relapse-Free Survival (DRFS)

  Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)

• 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 890 days)

• 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 390 days

• Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score

  Cycle 1 up to 390 days

Study Arms (2)

150 mg Abemaciclib + Endocrine Therapy (ET)

EXPERIMENTAL

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

Drug: Abemaciclib; Drug: Standard Adjuvant ET

Placebo + ET

ACTIVE COMPARATOR

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

Drug: Standard Adjuvant ET; Drug: Placebo

Interventions

Abemaciclib DRUG

Administered orally.

Also known as: LY2835219

150 mg Abemaciclib + Endocrine Therapy (ET)

Standard Adjuvant ET DRUG

Administered according to label instructions.

150 mg Abemaciclib + Endocrine Therapy (ET); Placebo + ET

Placebo DRUG

Administered orally.

Placebo + ET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have breast cancer with any of the following features:
• Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (115)

Palo Verde Cancer Specialists

Glendale, Arizona, 85304, United States

Location

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, 90024, United States

Location

Millennium Oncology - Hollywood

Hollywood, Florida, 33024, United States

Location

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

Location

Mt. Sinai Hospital PRiSMS

Chicago, Illinois, 60608, United States

Location

Cornell-Beshore Cancer Institute

Joplin, Missouri, 64804, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75230, United States

Location

Northwest Cancer Specialists PC

The Woodlands, Texas, 77380, United States

Location

Texas Oncology - Medical City Dallas

The Woodlands, Texas, 77380, United States

Location

US Oncology

The Woodlands, Texas, 77380, United States

Location

USO-Southern Cancer Center, P.C.

The Woodlands, Texas, 77380, United States

Location

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., 1125, Argentina

Location

Centro Medico Privado CEMAIC

Capital, Córdoba Province, X5008HHW, Argentina

Location

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, F5300COE, Argentina

Location

Sanatorio Parque

Salta, 4400, Argentina

Location

CER San Juan

San Juan, 5400, Argentina

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Ordensklinikum Linz

Linz, Upper Austria, 4020, Austria

Location

Medizinische Universität Wien

Vienna, Vienna, 1090, Austria

Location

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Clinique Saint Pierre

Ottignies, Wallonne, Région, 1340, Belgium

Location

Jan Yperman ziekenhuis

Ieper, West-Vlaanderen, 8900, Belgium

Location

AZ Groeninge Campus Kennedylaan

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, 22775-001, Brazil

Location

NotreDame Intermedica Saude S.A

São Paulo, 01229-010, Brazil

Location

Núcleo de Pesquisa Clínica da Rede São Camilo

São Paulo, 04014-002, Brazil

Location

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, 04543-000, Brazil

Location

Instituto de Ensino e Pesquisa São Lucas

São Paulo, 1236030, Brazil

Location

Afflilated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Medical University Union Hospital-1 Bingfanglou

Fuzhou Fujian, Fujian, 350001, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Hainan Cancer Hospital

Haikou, Hainan, 570000, China

Location

Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

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

Nanjing, Jiangsu, 210000, China

Location

The Third Hospital of Nanchang

Nanchang, Jiangxi, 330009, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

LinYi Cancer Hospital

Linyi, Shandong, 276000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer hospital

Chengdu, Sichuan, 610042, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

Xinjiang Medical University Cancer Hospital - Urumqi

Ürümqi, Xinjiang, 830011, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310006, China

Location

CHU Besançon

Besançon, Doubs, 25000, France

Location

Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519, France

Location

Centre Oscar Lambret

Lille, Nord, 59020, France

Location

Clinique Victor Hugo Le Mans

Le Mans, Pays de la Loire Region, 72000, France

Location

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68135, Germany

Location

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location

St. Vincenz-Krankenhaus Frauen- und Kinderklinik

Paderborn, North Rhine-Westphalia, 33098, Germany

Location

Alexandra Hospital

Athens, Attikí, 115 28, Greece

Location

General Oncology Hospital of Kifissia "Agioi Anargiroi"

Nea Kifissia, Attikí, 14564, Greece

Location

Euromedica General Clinic of Thessaloniki

Thessaloniki, Thessaloníki, 546 45, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 570 01, Greece

Location

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906, Israel

Location

Ospedale San Giovanni Moscati

Statte, Taranto, 74100, Italy

Location

Ospedale Mater Salutis

Legnago, Verona, 37045, Italy

Location

Ospedale Generale Provinciale Macerata

Macerata, 62100, Italy

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Chiba cancer center

Chiba, Chiba, 260-8717, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Gunma Prefectural Cancer Center

Ōta, Gunma, 373-0828, Japan

Location

Tsukuba University Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-8201, Japan

Location

St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Japanese Foundation for Cancer Research

Koto, Tokyo, 135-8550, Japan

Location

Showa University Hospital

Shinagawa, Tokyo, 142-8555, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Sagara Hospital

Kagoshima, 892-0833, Japan

Location

Kumamoto Shinto General Hospital

Kumamoto, 862-8655, Japan

Location

National Hospital Organization Osaka Medical Center

Osaka, 540-0006, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Shizuoka General Hospital

Shizuoka, 420-8527, Japan

Location

St. Luke's International Hospital

Tokyo, 104-8560, Japan

Location

Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, 45647, Mexico

Location

Grupo Medico Camino Sc

Mexico City, Mexico City, 3310, Mexico

Location

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], 22332, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, Kyǒnggi-do, 13496, South Korea

Location

Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 2841, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], 3722, South Korea

Location

CHUAC-Hospital Teresa Herrera

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

Location

H.R.U Málaga - Hospital Materno-infantil

Málaga, Málaga, 29011, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Quirónsalud Valencia

Valencia, 46010, Spain

Location

Brustzentrum Ostschweiz

Sankt Gallen, Canton of St. Gallen, 9016, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Bristol Haematology and Oncology Centre

Bristol, Bristol, City of, BS2 8ED, United Kingdom

Location

Colchester General Hospital

Colchester, Essex, CO4 5JL, United Kingdom

Location

Charing Cross Hospital

London, Hammersmith and Fulham, W6 8RF, United Kingdom

Location

Royal Marsden Hospital

Chelsea, London, SW3 6JJ, United Kingdom

Location

Ipswich Hospital

Ipswich, Suffolk, IP4 5PD, United Kingdom

Location

Royal Marsden Hospital (Sutton)

London, Sutton, SM2 5PT, United Kingdom

Location

The Christie

Manchester, M20 4BX, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study was terminated early due to inability to enroll study participants.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 12, 2021
• Study Start: May 10, 2021
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AU (2); KR (5); US (13); GB (7); HU (1); CN (21); IT (3); BE (4); FR (4); CH (2); TW (3); AR (7); ES (6); JP (19); ME (2); GR (4); BR (5); DE (4); IL (1)