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Breast NeoplasmsPhase 3eMonarcHERNCT04752332

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

A Phase 3 study testing Abemaciclib and Standard Adjuvant ET in people with Breast Neoplasms, run by Eli Lilly and Company at 115 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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+). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Abemaciclib and Standard Adjuvant ET
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
115 sitesin 20 countries
Study dates
10 May 2021to 26 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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.

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

115 sites in 20 countries.

115 sites in 20 countries

China21 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

  • Afflilated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Cancer hospital

    Chengdu, Sichuan, 610042

  • Fujian Medical University Union Hospital-1 Bingfanglou

    Fuzhou Fujian, Fujian, 350001

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

    Guangzhou, Guangdong, 510120

  • Hainan Cancer Hospital

    Haikou, Hainan, 570000

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006

  • LinYi Cancer Hospital

    Linyi, Shandong, 276000

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330009

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

    Nanjing, Jiangsu, 210000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

  • Xinjiang Medical University Cancer Hospital - Urumqi

    Ürümqi, Xinjiang, 830011

  • Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

Other trials in China

Japan19 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Chiba cancer center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Sagara Hospital

    Kagoshima, 892-0833

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8201

  • St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Osaka Medical Center

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-0828

  • Showa University Hospital

    Shinagawa, Tokyo, 142-8555

  • Shizuoka General Hospital

    Shizuoka, 420-8527

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Tsukuba University Hospital

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

United States13 sites

  • Mt. Sinai Hospital PRiSMS

    Chicago, Illinois, 60608

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Palo Verde Cancer Specialists

    Glendale, Arizona, 85304

  • Millennium Oncology - Hollywood

    Hollywood, Florida, 33024

  • Cornell-Beshore Cancer Institute

    Joplin, Missouri, 64804

  • TRIO-US (Translational Research in Oncology-US)

    Los Angeles, California, 90024

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Florida Cancer Specialists - North

    St. Petersburg, Florida, 33705

  • Northwest Cancer Specialists PC

    The Woodlands, Texas, 77380

  • Texas Oncology - Medical City Dallas

    The Woodlands, Texas, 77380

  • US Oncology

    The Woodlands, Texas, 77380

  • USO-Southern Cancer Center, P.C.

    The Woodlands, Texas, 77380

Other trials in United States

Argentina7 sites

  • Fundación Cenit Para La Investigación En Neurociencias

    CABA, Buenos Aires F.D., 1125

  • Centro Medico Privado CEMAIC

    Capital, Córdoba Province, X5008HHW

  • Fundación CORI para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Sanatorio Parque

    Salta, 4400

  • CER San Juan

    San Juan, 5400

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

United Kingdom7 sites

  • Bristol Haematology and Oncology Centre

    Bristol, Bristol, City of, BS2 8ED

  • Royal Marsden Hospital

    Chelsea, London, SW3 6JJ

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • Ipswich Hospital

    Ipswich, Suffolk, IP4 5PD

  • Charing Cross Hospital

    London, Hammersmith and Fulham, W6 8RF

  • Royal Marsden Hospital (Sutton)

    London, Sutton, SM2 5PT

  • The Christie

    Manchester, M20 4BX

Other trials in United Kingdom

Spain6 sites

  • CHUAC-Hospital Teresa Herrera

    A Coruña, A Coruña [La Coruña], 15006

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Clinico San Carlos

    Madrid, 28040

  • H.R.U Málaga - Hospital Materno-infantil

    Málaga, Málaga, 29011

  • Hospital Universitario de Canarias

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

  • Hospital Quirónsalud Valencia

    Valencia, 46010

Other trials in Spain

Brazil5 sites

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22775-001

  • NotreDame Intermedica Saude S.A

    São Paulo, 01229-010

  • Núcleo de Pesquisa Clínica da Rede São Camilo

    São Paulo, 04014-002

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, 04543-000

  • Instituto de Ensino e Pesquisa São Lucas

    São Paulo, 1236030

Other trials in Brazil

South Korea5 sites

  • Inha University Hospital

    Incheon, Incheon-gwangyeoksi [Incheon], 22332

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Kyǒnggi-do, 13496

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 2841

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722

Other trials in South Korea

Belgium4 sites

  • AZ Maria Middelares

    Ghent, Oost-Vlaanderen, 9000

  • Jan Yperman ziekenhuis

    Ieper, West-Vlaanderen, 8900

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West-Vlaanderen, 8500

  • Clinique Saint Pierre

    Ottignies, Wallonne, Région, 1340

Other trials in Belgium

France4 sites

  • CHU Besançon

    Besançon, Doubs, 25000

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000

  • Centre Oscar Lambret

    Lille, Nord, 59020

  • Institut de Cancérologie de Lorraine Alexis Vautrin

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

Other trials in France

Germany4 sites

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68135

  • St. Vincenz-Krankenhaus Frauen- und Kinderklinik

    Paderborn, North Rhine-Westphalia, 33098

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Greece4 sites

  • Alexandra Hospital

    Athens, Attikí, 115 28

  • General Oncology Hospital of Kifissia "Agioi Anargiroi"

    Nea Kifissia, Attikí, 14564

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, Thessaloníki, 546 45

  • European Interbalkan Medical Center

    Thessaloniki, 570 01

Other trials in Greece

Italy3 sites

  • Ospedale Mater Salutis

    Legnago, Verona, 37045

  • Ospedale Generale Provinciale Macerata

    Province of Macerata, 62100

  • Ospedale San Giovanni Moscati

    Statte, Taranto, 74100

Other trials in Italy

Taiwan3 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Austria2 sites

  • Ordensklinikum Linz

    Linz, Upper Austria, 4020

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

Mexico2 sites

  • Centro Oncológico Internacional (COI)

    Guadalajara, Jalisco, 45647

  • Grupo Medico Camino Sc

    Mexico City, Mexico City, 3310

Other trials in Mexico

Switzerland2 sites

  • Brustzentrum Ostschweiz

    Sankt Gallen, Canton of St. Gallen, 9016

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8401

Other trials in Switzerland

Hungary1 site

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9024

Other trials in Hungary

Israel1 site

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb, 6423906

Other trials in Israel

About this study

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

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.

Being tested
Abemaciclib, Standard Adjuvant ET, Placebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally.

  • Standard Adjuvant ETDrug

    Administered according to label instructions.

  • PlaceboDrug

    Administered orally.

Study groups in NCT04752332
Study groupRoleWhat they receive
150 mg Abemaciclib + Endocrine Therapy (ET)ExperimentalParticipants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).
Receives: Drug: Abemaciclib; Drug: Standard Adjuvant ET
Placebo + ETActive comparatorParticipants received placebo administered BID orally along with standard adjuvant ET.
Receives: Drug: Standard Adjuvant ET; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

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

  2. Distant Relapse-Free Survival (DRFS)

    DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.

    Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

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

  3. Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence

    Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

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

  4. Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score

    The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

    Measured: Cycle 1 up to 390 days

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

    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

    Measured: Cycle 1 up to 390 days

  6. Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib

    Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.

    Measured: Day 1 of Cycles 1-3 (Cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start10 May 2021
  3. Primary completion26 Jun 2024
  4. Study completion26 Jun 2024

Why it stopped: Study is terminated due to inability to enroll study participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752332
Sponsor's protocol ID
17384
Other IDs
I3Y-MC-JPCW, 2020-004035-24
Acronym
eMonarcHER
Status last verified
Jun 2025
First submitted
11 Feb 2021
Last updated
15 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib and Standard Adjuvant ET in people with Breast Neoplasms, run by Eli Lilly and Company at 115 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in China, Japan, United States, Argentina, United Kingdom and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease Free Survival (IDFS) (time frame: Randomization to Recurrence or Death from Any Cause (up to 890 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04752332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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