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

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• Status: Withdrawn
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Abemaciclib; Drug: Nonsteroidal Aromatase Inhibitor (NSAI)

• Study Type: Interventional
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

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, Investigación 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
      • Universitätsklinik Innsbruck
• Belgium
  • Brugge, Belgium, 8000
    • Algemeen Ziekenhuis St Jan Brugge
  • Haine-St.- Paul, Belgium, 7100
    • Hôpital 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 Cancer 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	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)	ORR	Baseline to Objective Disease Progression (Estimated up to 26 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DoR)	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)	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	CBR	Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)
Time to Response (TTR)	TTR	Baseline to Date of CR or PR (Estimated up to 26 Months)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 16, 2019
• Primary Completion (ANTICIPATED): March 23, 2022
• Study Completion (ANTICIPATED): March 23, 2023

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Aromatase Inhibitors
• Other Study ID 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