Clincosm LogoSign in Get a demo

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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03988114
Collaborator
(none)
0
Enrollment
119
Locations
1
Arm
42.2
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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 characteristics.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 16, 2019
Anticipated Primary Completion Date :
Mar 23, 2022
Anticipated Study Completion Date :
Mar 23, 2023

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)]

      PFS

    2. Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Baseline to Objective Disease Progression (Estimated up to 26 Months)]

      ORR

    Secondary Outcome Measures

    1. Duration of Response (DoR) [Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)]

      DoR

    2. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) [Baseline to Objective Disease Progression (Estimated up to 26 Months)]

      DCR

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

      CBR

    4. Time to Response (TTR) [Baseline to Date of CR or PR (Estimated up to 26 Months)]

      TTR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Cancer Center, P.C. Daphne Alabama United States 36526
    2 Arizona Oncology Associates, P.C. Tempe Arizona United States 85284
    3 Compassionate Cancer Care Medical Group Inc Fountain Valley California United States 92708
    4 California Cancer Associates Research and Excellence (cCARE) Fresno California United States 93720
    5 Beaver Medical Group Highland California United States 92346
    6 Pacific Cancer Care Monterey California United States 93940
    7 St. Joseph Hospital Orange California United States 92868
    8 Comprehensive Cancer Centers of the Desert Palm Springs California United States 92262
    9 California Cancer Associates in Research and Excellence San Marcos California United States 92069
    10 Cancer Center of Santa Barbara with Sansum Clinic Santa Barbara California United States 93105
    11 UCLA Medical Center Torrance California United States 90502
    12 Memorial Hospital Colorado Springs Colorado United States 80909
    13 Rocky Mountain Cancer Center Lone Tree Colorado United States 80124
    14 Medical Oncology Hematology Consultants, PA Newark Delaware United States 19713
    15 BayCare Medical Group Clearwater Florida United States 33756
    16 Florida Cancer Specialists Fort Myers Florida United States 33901
    17 Woodlands Medical Specialists Pensacola Florida United States 32503
    18 Cancer Specialists of North Florida -St Augustine Saint Augustine Florida United States 32086
    19 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    20 Florida Cancer Specialists Tallahassee Florida United States 32308
    21 Florida Cancer Specialists West Palm Beach Florida United States 33401
    22 Cleveland Clinic of Florida Weston Florida United States 33331
    23 Summit Cancer Care Savannah Georgia United States 31404
    24 Ingalls Memorial Hospital Harvey Illinois United States 60426
    25 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    26 Community Health Network Indianapolis Indiana United States 46219
    27 Central Maine Medical Center Lewiston Maine United States 04240
    28 York Hospital York Maine United States 03909
    29 HCA Midwest Kansas City Missouri United States 64132
    30 Oncology Hematology West Omaha Nebraska United States 68130
    31 Comprehensive Cancer Centers of Nevada Henderson Nevada United States 89052
    32 Valley Health System Paramus New Jersey United States 07652
    33 Broome Oncology LLC Johnson City New York United States 13790
    34 Abington Hematology Oncology Associates Horsham Pennsylvania United States 19044
    35 Charleston Hematology Oncology Associates Charleston South Carolina United States 29414
    36 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    37 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    38 Texas Oncology - Abilene Abilene Texas United States 79606
    39 Texas Oncology - Amarillo Amarillo Texas United States 79106
    40 Texas Oncology-Arlington South Arlington Texas United States 76014
    41 Texas Oncology Cancer Center Austin Texas United States 78731
    42 Texas Oncology - Bedford Bedford Texas United States 76022
    43 Texas Oncology P.A. Dallas Texas United States 75203
    44 Texas Oncology - Medical City Dallas Dallas Texas United States 75230
    45 Texas Oncology - Dallas Presbyterian Hospital Dallas Texas United States 75231
    46 Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    47 Texas Oncology - Marnie McFadden Ward Cancer Center Dallas Texas United States 77702
    48 Texas Oncology P.A. El Paso Texas United States 79902
    49 Texas Oncology Flower Mound Flower Mound Texas United States 75028
    50 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    51 Texas Oncology-Memorial City Houston Texas United States 77024
    52 Renovatio Clinical Houston Texas United States 77056
    53 Texas Oncology - McAllen McAllen Texas United States 78503
    54 Texas Oncology-McKinney McKinney Texas United States 75771
    55 Texas Oncology- Mesquite Mesquite Texas United States 75150
    56 Texas Oncology - Midland Allison Cancer Center Midland Texas United States 79701
    57 Texas Oncology - Paris Paris Texas United States 75460
    58 Texas Oncology-Plano East Plano Texas United States 75075
    59 Texas Oncology-Plano West Plano Texas United States 75093
    60 Texas Oncology - San Antonio Medical Center San Antonio Texas United States 78217
    61 Texas Oncology-Sherman Sherman Texas United States 75090-0504
    62 US Oncology The Woodlands Texas United States 77380
    63 Tyler Cancer Center Tyler Texas United States 75702
    64 Texas Oncology-Deke Slayton Cancer Center Webster Texas United States 77598-4219
    65 Texas Oncology-Wichital Falls Texoma Cancer Center Wichita Falls Texas United States 76310
    66 Intermountain Medical Center Saint George Utah United States 84790
    67 Hematology Oncology Associates of Fredericksburg Inc. Fredericksburg Virginia United States 22408
    68 Virginia Oncology Associates Norfolk Virginia United States 23502
    69 Oncology and Hematology Associates of Southwest Virginia Inc Salem Virginia United States 24153
    70 Shenandoah Oncology, P.C. Winchester Virginia United States 22601
    71 Centro de Oncologia e Investigacion Buenos Aires Berazategui Buenos Aires Argentina B1884BBF
    72 CEMEDIC Caba Buenos Aires Argentina C1440CFD
    73 CENIT Centro de Neurociencias, Investigación y Tratamiento Caba Ciudad Autonoma Buenos Aires Argentina C1125ABD
    74 Centro Medico San Roque San Miguel de Tucumán Tucuman Argentina T4000IAK
    75 Clinica Adventista de Belgrano Ciudad Autonoma Buenos Aires Argentina C1430EGF
    76 Sanatorio Parque Salta Argentina 4400
    77 Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan San Juan Argentina J5402DIL
    78 Centro para la Atencion Integral del Paciente Oncologico Tucumain Argentina 4000
    79 Universitätsklinikum Graz Graz Steiermark Austria 8036
    80 Universitätsklinik Innsbruck Innsbruck Tirol Austria 6020
    81 Universitätsklinikum Salzburg Salzburg Austria 5020
    82 AKH Wien Austria 1090
    83 Algemeen Ziekenhuis St Jan Brugge Brugge Belgium 8000
    84 Hopital De Jolimont Haine-St.- Paul Belgium 7100
    85 VZW REgional Ziekenhuis Jan Yperman Ieper Belgium 8900
    86 Clinique Saint Pierre Ottignies Ottignies Belgium 1340
    87 Núcleo de Oncologia da Bahia Salvador Bahia Brazil 41170
    88 Instituto de Cancer de Londrina Londrina Parana Brazil 86015-520
    89 Hospital de Caridade Ijui Ijui Rio Grande Do Sul Brazil 98700 000
    90 Hospital São Lucas - PUCRS - ONCOLOGY Porto Alegre Rio Grande Do Sul Brazil 90610-000
    91 Instituto COI de Pesquisa Educação e Gestão Rio de Janeiro RJ Brazil 22793-080
    92 Hospital Bruno Born de Lajeado Lajeado RS Brazil 95900-000
    93 Fundação PIO XII Barretos Sao Paulo Brazil 14784700
    94 Hospital de Base Fac de Medicina de Sao Jose do Rio Preto Sao Jose Rio Preto Sao Paulo Brazil 15090-000
    95 Faculdade de Medicina do ABC Santo Andre SP Brazil 09060-020
    96 Hospital das Clinicas da FMRP Ribeirao Preto São Paulo Brazil 14048-900
    97 INCA - Instituto Nacional Do Cancer Rio de Janeiro Brazil 20231
    98 Fundacao Antonio Prudente-Hosp. do Cancer AC Camargo Sao Paulo Brazil 01509-900
    99 Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology São Paulo Brazil 01246
    100 Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária São Paulo Brazil 01317-000
    101 Clinica Onco Star São Paulo Brazil 04501-000
    102 Hämatologisch-Onkologische Praxis Augsburg Augsburg Bavaria Germany 86150
    103 Universität Leipzig - Universitätsklinikum Leipzig Sachsen Germany 04103
    104 St. Vincenz-Krankenhaus GmbH-Frauen- und Kinderklinik St. Louise Paderborn Germany 33098
    105 Istituto Tumori Fondazione G. Pascale IRCCS Napoli Naples Italy 80131
    106 Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro Candiolo Torino Italy 10060
    107 Policlinico S. Orsola Malpighi - Universita di Bologna Bologna Italy 40138
    108 Azienda Ospedaliera Universitaria Ospedale San Martino di Genova Genova Italy 16132
    109 IRCCS Ospedale San Raffaele Milano Italy 20132
    110 Istituto Oncologico Veneto Padova Italy 35128
    111 Centro di Riferimento Oncologico Udine Italy 33100
    112 Puerto Rico Hematology/Oncology Group Bayamon Puerto Rico 00959
    113 Ad-Vance Medical Research Ponce Puerto Rico 00717
    114 E-DA Cancer Hospital Kaohsiung Taiwan 82445
    115 China Medical University Hospital Taichung Taiwan 40447
    116 Taichung Veterans General Hospital Taichung Taiwan 40705, ROC
    117 National Cheng Kung University Hospital Tainan Taiwan 704
    118 MacKay Memorial Hospital Taipei Taiwan 10449
    119 Koo Foundation Sun Yan-Sen Cancer Center Taipei Taiwan 11259

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03988114
    Other Study ID Numbers:
    • 17395
    • I3Y-MC-JPCX
    • 2019-001781-16
    First Posted:
    Jun 17, 2019
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Aromatase Inhibitors

    Study Results

    No Results Posted as of Sep 6, 2019