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Metastatic Breast CancerPhase 4proMONARCHNCT03988114

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

A Phase 4 study testing Abemaciclib and Nonsteroidal Aromatase Inhibitor (NSAI) in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 119 sites in 9 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Abemaciclib and Nonsteroidal Aromatase Inhibitor (NSAI)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
119 sitesin 9 countries
Study dates
16 Sep 2019to 23 Mar 2023
Phase
Phase 4
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

119 sites in 9 countries.

119 sites in 9 countries

United States70 sites

  • Texas Oncology - Abilene

    Abilene, Texas, 79606

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology-Arlington South

    Arlington, Texas, 76014

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • BayCare Medical Group

    Clearwater, Florida, 33756

  • Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Texas Oncology P.A.

    Dallas, Texas, 75203

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology - Marnie McFadden Ward Cancer Center

    Dallas, Texas, 77702

  • Southern Cancer Center, P.C.

    Daphne, Alabama, 36526

  • Texas Oncology P.A.

    El Paso, Texas, 79902

  • Texas Oncology Flower Mound

    Flower Mound, Texas, 75028

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Compassionate Cancer Care Medical Group Inc

    Fountain Valley, California, 92708

  • Hematology Oncology Associates of Fredericksburg Inc.

    Fredericksburg, Virginia, 22408

  • California Cancer Associates Research and Excellence (cCARE)

    Fresno, California, 93720

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Beaver Medical Group

    Highland, California, 92346

  • Abington Hematology Oncology Associates

    Horsham, Pennsylvania, 19044

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Renovatio Clinical

    Houston, Texas, 77056

  • Community Health Network

    Indianapolis, Indiana, 46219

  • Broome Oncology LLC

    Johnson City, New York, 13790

  • HCA Midwest

    Kansas City, Missouri, 64132

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Rocky Mountain Cancer Center

    Lone Tree, Colorado, 80124

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • Texas Oncology-McKinney

    McKinney, Texas, 75771

  • Texas Oncology- Mesquite

    Mesquite, Texas, 75150

  • Texas Oncology - Midland Allison Cancer Center

    Midland, Texas, 79701

  • Pacific Cancer Care

    Monterey, California, 93940

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • Illinois Cancer Specialists-Niles

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Oncology Hematology West

    Omaha, Nebraska, 68130

  • St. Joseph Hospital

    Orange, California, 92868

  • Comprehensive Cancer Centers of the Desert

    Palm Springs, California, 92262

  • Valley Health System

    Paramus, New Jersey, 07652

  • Texas Oncology - Paris

    Paris, Texas, 75460

  • Woodlands Medical Specialists

    Pensacola, Florida, 32503

  • Texas Oncology-Plano East

    Plano, Texas, 75075

  • Texas Oncology-Plano West

    Plano, Texas, 75093

  • Cancer Specialists of North Florida -St Augustine

    Saint Augustine, Florida, 32086

  • Oncology and Hematology Associates of Southwest Virginia Inc

    Salem, Virginia, 24153

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78217

  • California Cancer Associates in Research and Excellence

    San Marcos, California, 92069

  • Cancer Center of Santa Barbara with Sansum Clinic

    Santa Barbara, California, 93105

  • Summit Cancer Care

    Savannah, Georgia, 31404

  • Texas Oncology-Sherman

    Sherman, Texas, 75090-0504

  • Intermountain Medical Center

    St. George, Utah, 84790

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308

  • Arizona Oncology Associates, P.C.

    Tempe, Arizona, 85284

  • US Oncology

    The Woodlands, Texas, 77380

  • UCLA Medical Center

    Torrance, California, 90502

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Texas Oncology-Deke Slayton Cancer Center

    Webster, Texas, 77598-4219

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Cleveland Clinic of Florida

    Weston, Florida, 33331

  • Texas Oncology-Wichital Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

  • York Hospital

    York Village, Maine, 03909

Other trials in United States

Brazil15 sites

  • Fundação PIO XII

    Barretos, São Paulo, 14784700

  • Hospital de Caridade Ijui

    Ijuí, Rio Grande do Sul, 98700 000

  • Hospital Bruno Born de Lajeado

    Lajeado, Rio Grande do Sul, 95900-000

  • Instituto de Cancer de Londrina

    Londrina, Paraná, 86015-520

  • Hospital São Lucas - PUCRS - ONCOLOGY

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital das Clinicas da FMRP

    Ribeirão Preto, São Paulo, 14048-900

  • Instituto COI de Pesquisa Educação e Gestão

    Rio de Janeiro, Rio de Janeiro, 22793-080

  • INCA - Instituto Nacional Do Cancer

    Rio de Janeiro, 20231

  • Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 41170

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-020

  • Hospital de Base Fac de Medicina de Sao Jose do Rio Preto

    Sao Jose Rio Preto, São Paulo, 15090-000

  • Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

    São Paulo, 01246

  • Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária

    São Paulo, 01317-000

  • Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo

    São Paulo, 01509-900

  • Clinica Onco Star

    São Paulo, 04501-000

Other trials in Brazil

Argentina8 sites

  • Centro de Oncologia e Investigacion Buenos Aires

    Berazategui, Buenos Aires, B1884BBF

  • CEMEDIC

    CABA, Buenos Aires, C1440CFD

  • CENIT Centro de Neurociencias, Investigación y Tratamiento

    CABA, Ciudad Autonoma Buenos Aires, C1125ABD

  • Clinica Adventista de Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF

  • Sanatorio Parque

    Salta, 4400

  • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

    San Juan, J5402DIL

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, T4000IAK

  • Centro para la Atencion Integral del Paciente Oncologico

    Tucumain, 4000

Other trials in Argentina

Italy7 sites

  • Policlinico S. Orsola Malpighi - Universita di Bologna

    Bologna, 40138

  • Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

    Candiolo, Torino, 10060

  • Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

    Genova, 16132

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Istituto Tumori Fondazione G. Pascale IRCCS

    Naples, Naples, 80131

  • Istituto Oncologico Veneto

    Padova, 35128

  • Centro di Riferimento Oncologico

    Udine, 33100

Other trials in Italy

Taiwan6 sites

  • E-DA Cancer Hospital

    Kaohsiung City, 82445

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705, ROC

  • National Cheng Kung University Hospital

    Tainan, 704

  • MacKay Memorial Hospital

    Taipei, 10449

  • Koo Foundation Sun Yan-Sen Cancer Center

    Taipei, 11259

Other trials in Taiwan

Austria4 sites

  • Universitätsklinikum Graz

    Graz, Styria, 8036

  • Universitätsklinik Innsbruck

    Innsbruck, Tyrol, 6020

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • AKH

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Algemeen Ziekenhuis St Jan Brugge

    Bruges, 8000

  • Hopital De Jolimont

    Haine-St.- Paul, 7100

  • VZW REgional Ziekenhuis Jan Yperman

    Ieper, 8900

  • Clinique Saint Pierre Ottignies

    Ottignies, 1340

Other trials in Belgium

Germany3 sites

  • Hämatologisch-Onkologische Praxis Augsburg

    Augsburg, Bavaria, 86150

  • Universität Leipzig - Universitätsklinikum

    Leipzig, Saxony, 04103

  • St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise

    Paderborn, 33098

Other trials in Germany

Puerto Rico2 sites

  • Puerto Rico Hematology/Oncology Group

    Bayamón, PR, 00959

  • Ad-Vance Medical Research

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI)
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

  • Nonsteroidal Aromatase Inhibitor (NSAI)Drug

    Letrozole administered orally or anastrozole administered orally (physician choice)

Study groups in NCT03988114
Study groupRoleWhat they receive
Abemaciclib + NSAIExperimentalAbemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
Receives: Drug: Abemaciclib; Drug: Nonsteroidal Aromatase Inhibitor (NSAI)

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS

    Measured: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)

  2. Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)

    ORR

    Measured: Baseline to Objective Disease Progression (Estimated up to 26 Months)

Secondary outcomes (4)

  1. Duration of Response (DoR)

    DoR

    Measured: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)

  2. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)

    DCR

    Measured: Baseline to Objective Disease Progression (Estimated up to 26 Months)

  3. 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

    CBR

    Measured: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)

  4. Time to Response (TTR)

    TTR

    Measured: Baseline to Date of CR or PR (Estimated up to 26 Months)

Timeline

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

  1. First posted17 Jun 2019
  2. Study start16 Sep 2019 (estimated)
  3. Primary completion23 Mar 2022 (estimated)
  4. Study completion23 Mar 2023 (estimated)

Why it stopped: Strategic decision due to emerging new data for patients with HR+, HER2- metastatic breast cancer.

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03988114
Sponsor's protocol ID
17395
Other IDs
I3Y-MC-JPCX, 2019-001781-16, 2019
Acronym
proMONARCH
Status last verified
Sep 2019
First submitted
12 Jun 2019
Last updated
6 Sep 2019
Results posted
No
Data monitoring committee
No
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 4 study testing Abemaciclib and Nonsteroidal Aromatase Inhibitor (NSAI) in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 119 sites in 9 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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Brazil, Argentina, Italy, Taiwan and 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression Free Survival (PFS) (time frame: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)). The study lists 2 primary outcomes in all. 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 NCT03988114.

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 6 Sep 2019.

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