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

June 26, 2025 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • La Rioja, Argentina, F5300COE
        • Fundación CORI para la Investigación y Prevención del Cáncer
      • Salta, Argentina, 4400
        • Sanatorio Parque
      • San Juan, Argentina, 5400
        • CER San Juan
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto de Investigaciones Clinicas Mar del Plata
    • Ciudad Autónoma De Buenos Aires
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, 1125
        • Fundación CENIT para la Investigación en Neurociencias
    • Córdoba
      • Capital, Córdoba, Argentina, X5008HHW
        • Centro Medico Privado CEMAIC
    • Tucumán
      • San Miguel de Tucumán, Tucumán, Argentina, 4000
        • Centro Medico San Roque
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Ordensklinikum Linz
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • AZ Maria Middelares
    • Wallonne, Région
      • Ottignies, Wallonne, Région, Belgium, 1340
        • Clinique Saint Pierre
    • West-Vlaanderen
      • Ieper, West-Vlaanderen, Belgium, 8900
        • Jan Yperman Ziekenhuis
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge Campus Kennedylaan
  • Brazil
      • Rio de Janeiro, Brazil, 22775-001
        • Instituto de Educacao, Pesquisa e Gestao em Saude
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa Clínica da Rede São Camilo
      • São Paulo, Brazil, 04543-000
        • Instituto D'Or de Pesquisa e Ensino (IDOR)
      • São Paulo, Brazil, 01229-010
        • NotreDame Intermedica Saude S.A
      • São Paulo, Brazil, 1236030
        • Instituto de Ensino e Pesquisa São Lucas
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Afflilated Hospital of Bengbu Medical College
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100034
        • Peking University People's Hospital
    • Fujian
      • Fuzhou Fujian, Fujian, China, 350001
        • Fujian Medical University Union Hospital-1 Bingfanglou
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Hainan
      • Haikou, Hainan, China, 570000
        • Hainan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430022
        • Tongji Medical College of Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Jiangxi
      • Nanchang, Jiangxi, China, 330009
        • The Third Hospital of Nanchang
    • Jilin
      • Changchun, Jilin, China
        • The Second Hospital of Jilin University
    • Shandong
      • Linyi, Shandong, China, 276000
        • Linyi Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, Sichuan, China, 610042
        • Sichuan Cancer Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Xinjiang Medical University Cancer Hospital - Urumqi
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University
      • Hangzhou, Zhejiang, China, 310006
        • The First People's Hospital of Hangzhou
  • France
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU Besançon
    • Meurthe-et-Moselle
      • Vandoeuvre-lès-Nancy, Meurthe-et-Moselle, France, 54519
        • Institut de Cancérologie de Lorraine ALEXIS VAUTRIN
    • Nord
      • Lille, Nord, France, 59020
        • Centre Oscar Lambret
    • Pays-de-la-Loire
      • Le Mans, Pays-de-la-Loire, France, 72000
        • Clinique Victor Hugo Le Mans
  • Germany
    • Baden-Württemberg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Klinikum Ludwigsburg
      • Mannheim, Baden-Württemberg, Germany, 68135
        • Universitätsmedizin Mannheim
      • Ulm, Baden-Württemberg, Germany, 89075
        • Universitaetsklinikum Ulm
    • Nordrhein-Westfalen
      • Paderborn, Nordrhein-Westfalen, Germany, 33098
        • St. Vincenz-Krankenhaus Frauen- und Kinderklinik
  • Greece
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center
    • Attikí
      • Athina, Attikí, Greece, 115 28
        • Alexandra Hospital
      • Nea Kifissia, Attikí, Greece, 14564
        • General Oncology Hospital of Kifissia "Agioi Anargiroi"
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 546 45
        • Euromedica General Clinic of Thessaloniki
  • Hungary
    • Győr-Moson-Sopron
      • Gyor, Győr-Moson-Sopron, Hungary, 9024
        • Petz Aladar Egyetemi Oktato Korhaz
  • Israel
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Sourasky Medical Center
  • Italy
      • Macerata, Italy, 62100
        • Ospedale Generale Provinciale Macerata
    • Taranto
      • Statte, Taranto, Italy, 74100
        • Ospedale San Giovanni Moscati
    • Verona
      • Legnago, Verona, Italy, 37045
        • Ospedale Mater Salutis
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka Medical Center
      • Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital
      • Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Gunma
      • Ota, Gunma, Japan, 373-0828
        • Gunma Prefectural Cancer Center
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Tsukuba University Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8201
        • Ishikawa Prefectural Central Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research
      • Shinagawa, Tokyo, Japan, 142-8555
        • Showa University Hospital
  • Korea, Republic of
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
        • Inha University Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seongnam-si, Kyǒnggi-do, Korea, Republic of, 13496
        • CHA Bundang Medical Center, CHA University
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 3722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 2841
        • Korea University Anam Hospital
  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 3310
        • Grupo Medico Camino Sc
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45647
        • Centro Oncológico Internacional (COI)
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Valencia, Spain, 46010
        • Hospital Quironsalud Valencia
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • CHUAC-Hospital Teresa Herrera
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Málaga
      • Malaga, Málaga, Spain, 29011
        • H.R.U Málaga - Hospital Materno-infantil
    • Santa Cruz De Tenerife
      • San Cristobal de La laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
  • Switzerland
    • Sankt Gallen
      • St.Gallen, Sankt Gallen, Switzerland, 9016
        • Brustzentrum Ostschweiz
    • Zürich
      • Winterthur, Zürich, Switzerland, 8401
        • Kantonsspital Winterthur
  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • The Christie
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
    • Essex
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Colchester General Hospital
    • Hammersmith And Fulham
      • London, Hammersmith And Fulham, United Kingdom, W6 8RF
        • Charing Cross Hospital
    • London
      • Chelsea, London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
    • Suffolk
      • Ipswich, Suffolk, United Kingdom, IP4 5PD
        • Ipswich Hospital
    • Sutton
      • London, Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital (Sutton)
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Cancer Specialists
    • California
      • Los Angeles, California, United States, 90024
        • TRIO-US (Translational Research in Oncology-US)
    • Florida
      • Hollywood, Florida, United States, 33024
        • Millennium Oncology - Hollywood
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists - North
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Mt. Sinai Hospital PRiSMS
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Cornell-Beshore Cancer Institute
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute SCRI
    • Texas
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City Dallas
      • The Woodlands, Texas, United States, 77380
        • US Oncology
      • The Woodlands, Texas, United States, 77380
        • Northwest Cancer Specialists PC
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology - Medical City Dallas
      • The Woodlands, Texas, United States, 77380
        • USO-Southern Cancer Center, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Drug: Abemaciclib
Administered orally.
Other Names:
  • LY2835219
Drug: Standard Adjuvant ET
Administered according to label instructions.
Active Comparator: Placebo + ET
Participants received placebo administered BID orally along with standard adjuvant ET.
Drug: Placebo
Administered orally.
Drug: Standard Adjuvant ET
Administered according to label instructions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Invasive Disease Free Survival (IDFS)
Time Frame: Randomization to Recurrence or Death from Any Cause (up to 890 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Randomization to Death from Any Cause (up to 890 days)
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.
Randomization to Death from Any Cause (up to 890 days)
Distant Relapse-Free Survival (DRFS)
Time Frame: Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)

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.
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
Time Frame: Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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
Time Frame: Cycle 1 up to 390 days
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.
Cycle 1 up to 390 days
Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
Time Frame: Cycle 1 up to 390 days
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.
Cycle 1 up to 390 days
Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
Time Frame: Day 1 of Cycles 1-3 (Cycle = 28 days)
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Day 1 of Cycles 1-3 (Cycle = 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17384
  • I3Y-MC-JPCW (Other Identifier: Eli Lilly and Company)
  • 2020-004035-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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