A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer (proMONARCH)

September 4, 2019 updated by: Eli Lilly and Company

A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Study Overview

Status

Status

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Withdrawn

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

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 4

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.
Available

Available

  • 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.
 outside the clinical trial. 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
      • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista de Belgrano
      • Salta, Argentina, 4400
        • Sanatorio Parque
      • San Juan, Argentina, J5402DIL
        • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
      • Tucumain, Argentina, 4000
        • Centro para la Atención Integral del paciente Oncológico
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1884BBF
        • Centro de Oncologia e Investigacion Buenos Aires
      • Caba, Buenos Aires, Argentina, C1440CFD
        • CEMEDIC
    • Ciudad Autonoma Buenos Aires
      • Caba, Ciudad Autonoma Buenos Aires, Argentina, C1125ABD
        • CENIT Centro de Neurociencias, Investigacion y Tratamiento
    • Tucuman
      • San Miguel de Tucumán, Tucuman, Argentina, T4000IAK
        • Centro Medico San Roque
  • Austria
      • Salzburg, Austria, 5020
        • Universitätsklinikum Salzburg
      • Wien, Austria, 1090
        • AKH
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Universitätsklinikum Graz
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Universitatsklinik Innsbruck
  • Belgium
      • Brugge, Belgium, 8000
        • Algemeen Ziekenhuis St Jan Brugge
      • Haine-St.- Paul, Belgium, 7100
        • Hopital De Jolimont
      • Ieper, Belgium, 8900
        • VZW REgional Ziekenhuis Jan Yperman
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre Ottignies
  • Brazil
      • Rio de Janeiro, Brazil, 20231
        • INCA - Instituto Nacional Do Cancer
      • Sao Paulo, Brazil, 01509-900
        • Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo
      • São Paulo, Brazil, 01317-000
        • Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
      • São Paulo, Brazil, 01246
        • Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
      • São Paulo, Brazil, 04501-000
        • Clinica Onco Star
    • Bahia
      • Salvador, Bahia, Brazil, 41170
        • Nucleo de Oncologia da Bahia
    • Parana
      • Londrina, Parana, Brazil, 86015-520
        • Instituto de Câncer de Londrina
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22793-080
        • Instituto COI de Pesquisa Educação e Gestão
    • RS
      • Lajeado, RS, Brazil, 95900-000
        • Hospital Bruno Born de Lajeado
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700 000
        • Hospital de Caridade Ijui
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Hospital São Lucas - PUCRS - ONCOLOGY
    • SP
      • Santo Andre, SP, Brazil, 09060-020
        • Faculdade de Medicina do ABC
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784700
        • Fundacao Pio XII
      • Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000
        • Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
    • São Paulo
      • Ribeirao Preto, São Paulo, Brazil, 14048-900
        • Hospital das Clinicas da FMRP
  • Germany
      • Paderborn, Germany, 33098
        • St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise
    • Bavaria
      • Augsburg, Bavaria, Germany, 86150
        • Hämatologisch-Onkologische Praxis Augsburg
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universität Leipzig - Universitätsklinikum
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola Malpighi - Universita di Bologna
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Udine, Italy, 33100
        • Centro di Riferimento Oncologico
    • Naples
      • Napoli, Naples, Italy, 80131
        • Istituto Tumori Fondazione G. Pascale IRCCS
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
  • Puerto Rico
      • Bayamon, Puerto Rico, 00959
        • Puerto Rico Hematology/Oncology Group
      • Ponce, Puerto Rico, 00717
        • Ad-Vance Medical Research
  • Taiwan
      • Kaohsiung, Taiwan, 82445
        • E-Da Cancer Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705, ROC
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 11259
        • Koo Foundation Sun Yan-Sen Cancer Center
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, P.C.
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Arizona Oncology Associates, P.C.
    • California
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Medical Group Inc
      • Fresno, California, United States, 93720
        • California Cancer Associates Research and Excellence (cCARE)
      • Highland, California, United States, 92346
        • Beaver Medical Group
      • Monterey, California, United States, 93940
        • Pacific Cancer Care
      • Orange, California, United States, 92868
        • St. Joseph Hospital
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Centers of the Desert
      • San Marcos, California, United States, 92069
        • California Cancer Associates in Research and Excellence
      • Santa Barbara, California, United States, 93105
        • Cancer Center of Santa Barbara with Sansum Clinic
      • Torrance, California, United States, 90502
        • UCLA Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Hospital
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants, PA
    • Florida
      • Clearwater, Florida, United States, 33756
        • BayCare Medical Group
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists
      • Saint Augustine, Florida, United States, 32086
        • Cancer Specialists of North Florida -St Augustine
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • Tallahassee, Florida, United States, 32308
        • Florida Cancer Specialists
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
      • Weston, Florida, United States, 33331
        • Cleveland Clinic of Florida
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Summit Cancer Care
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists-Niles
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Community Health Network
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Medical Center
      • York, Maine, United States, 03909
        • York Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Valley Health System
    • New York
      • Johnson City, New York, United States, 13790
        • Broome Oncology LLC
    • Pennsylvania
      • Horsham, Pennsylvania, United States, 19044
        • Abington Hematology Oncology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute SCRI
    • Texas
      • Abilene, Texas, United States, 79606
        • Texas Oncology - Abilene
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - Amarillo
      • Arlington, Texas, United States, 76014
        • Texas Oncology-Arlington South
      • Austin, Texas, United States, 78731
        • Texas Oncology Cancer Center
      • Bedford, Texas, United States, 76022
        • Texas Oncology - Bedford
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Dallas Presbyterian Hospital
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City Dallas
      • Dallas, Texas, United States, 75203
        • Texas Oncology P.A.
      • Dallas, Texas, United States, 77702
        • Texas Oncology - Marnie McFadden Ward Cancer Center
      • El Paso, Texas, United States, 79902
        • Texas Oncology P.A.
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology Flower Mound
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, United States, 77024
        • Texas Oncology-Memorial City
      • Houston, Texas, United States, 77056
        • Renovatio Clinical
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • McKinney, Texas, United States, 75771
        • Texas Oncology-McKinney
      • Mesquite, Texas, United States, 75150
        • Texas Oncology- Mesquite
      • Midland, Texas, United States, 79701
        • Texas Oncology - Midland Allison Cancer Center
      • Paris, Texas, United States, 75460
        • Texas Oncology - Paris
      • Plano, Texas, United States, 75093
        • Texas Oncology-Plano West
      • Plano, Texas, United States, 75075
        • Texas Oncology-Plano East
      • San Antonio, Texas, United States, 78217
        • Texas Oncology - San Antonio Medical Center
      • Sherman, Texas, United States, 75090-0504
        • Texas Oncology-Sherman
      • The Woodlands, Texas, United States, 77380
        • US Oncology
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
      • Webster, Texas, United States, 77598-4219
        • Texas Oncology-Deke Slayton Cancer Center
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology-Wichital Falls Texoma Cancer Center
    • Utah
      • Saint George, Utah, United States, 84790
        • Intermountain Medical Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg Inc.
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Salem, Virginia, United States, 24153
        • Oncology and Hematology Associates of Southwest Virginia Inc
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology, 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis

  • Participants must have 1 or more of the following:

    • A high grade tumor in tissue
    • Negative progesterone receptor (PR) status
    • Have cancer that has spread to the liver
    • Have a treatment-free interval (TFI) <36 months
  • Participants must have HR+, HER2- breast cancer
  • Participants must have adequate organ function

Exclusion Criteria:

  • Participants must not have cancer that has spread to other organs that has severely affected their function
  • Participants must not have cancer that has spread to the brain that is unstable or untreated
  • Participants must not have received endocrine therapy in the metastatic setting
  • Participants must not have known active infection
  • Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
  • Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 & 6 inhibitor or everolimus

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Abemaciclib + NSAI
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole administered orally or anastrozole administered orally (physician choice)

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
Progression Free Survival (PFS)
Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
PFS
Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline to Objective Disease Progression (Estimated up to 26 Months)
ORR
Baseline to Objective Disease Progression (Estimated up to 26 Months)

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
Duration of Response (DoR)
Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)
DoR
Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)
Time Frame: Baseline to Objective Disease Progression (Estimated up to 26 Months)
DCR
Baseline to Objective Disease Progression (Estimated up to 26 Months)
Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months
Time Frame: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
CBR
Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
Time to Response (TTR)
Time Frame: Baseline to Date of CR or PR (Estimated up to 26 Months)
TTR
Baseline to Date of CR or PR (Estimated up to 26 Months)

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

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 (ANTICIPATED)

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.
September 16, 2019

Primary Completion (ANTICIPATED)

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.
March 23, 2022

Study Completion (ANTICIPATED)

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.
March 23, 2023

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).
June 12, 2019

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.
June 12, 2019

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.
June 17, 2019

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.
September 6, 2019

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.
September 4, 2019

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.
September 1, 2019

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.
  • 17395
  • I3Y-MC-JPCX (OTHER: Eli Lilly and Company)
  • 2019-001781-16 (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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