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A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675231
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Tumor HER-2 Positive Breast Cancer Drug: Abemaciclib Drug: Trastuzumab Drug: Fulvestrant Drug: Standard of Care Single Agent Chemotherapy Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date : May 23, 2016
Actual Primary Completion Date : April 8, 2019
Estimated Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Abemaciclib + Trastuzumab + Fulvestrant
Abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a maintenance dose IV infusion on Day 1 of each subsequent cycle; plus fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
Drug: Abemaciclib
Administered Orally
Other Name: LY2835219

Drug: Trastuzumab
Administered IV

Drug: Fulvestrant
Administered IM

Experimental: Abemaciclib + Trastuzumab
Abemaciclib given orally Q12H of a 21-day cycle; plus trastuzumab IV infusion on Day 1 of the cycle then a maintenance dose IV infusion on Day 1 of each subsequent cycle.
Drug: Abemaciclib
Administered Orally
Other Name: LY2835219

Drug: Trastuzumab
Administered IV

Active Comparator: Trastuzumab + Standard of Care Chemotherapy
Trastuzumab IV infusion on Day 1 of a 21-day cycle then a maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Drug: Trastuzumab
Administered IV

Drug: Standard of Care Single Agent Chemotherapy
Standard-of-care single-agent chemotherapy of physician's choice administered according to product label




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 24 Months) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Estimated up to 48 Months) ]
  2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) [ Time Frame: Baseline to Objective Disease Progression (Estimated up to 24 Months) ]
  3. 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 24 Months) ]
  4. Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) [ Time Frame: Baseline to Objective Disease Progression (Estimated up to 24 Months) ]
  5. Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR) [ Time Frame: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 24 Months) ]
  6. Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) [ Time Frame: Baseline, up to 30 Days After Treatment Discontinuation (Estimated up to 24 Months) ]
  7. Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) [ Time Frame: Baseline, up to 30 Days After Treatment Discontinuation (Estimated up to 24 Months) ]
  8. Change from Baseline in Health Status on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to 30 Days After Treatment Discontinuation (Estimated up to 24 Months) ]
  9. Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and its Metabolites, Fulvestrant, and Trastuzumab [ Time Frame: Predose Cycle 1 through Cycle 5 Day 1 (Approximately 4 Months) ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of HR+, HER2+ breast cancer (BC)
  • unresectable locally advanced recurrent BC or metastatic BC
  • adequate tumor tissue available prior to randomization
  • measurable and/or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • previously received:

    • at least 2 HER2-directed therapies for advanced disease
    • participant must have received trastuzumab emtansine (T-DM1) in any disease setting
  • must have received a taxane in any disease setting
  • may have received any endocrine therapy (excluding fulvestrant)
  • have postmenopausal status
  • performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale
  • left ventricular ejection fraction (LVEF) of 50% or higher at baseline
  • adequate organ function
  • negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib id menopause induced by gonadotropin-releasing hormone (GnRH) agonist or radiation
  • discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
  • discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy
  • are able to swallow capsules

Exclusion Criteria:

  • have visceral crisis
  • known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms
  • had major surgery within 14 days prior to randomization
  • received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor
  • received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
  • have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
  • history within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina
  • history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
  • history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
  • active bacterial, fungal infection, or detectable viral infection
  • have received any recent (within 28 days prior to randomization) live virus vaccination
  • hypersensitivity to trastuzumab, murine proteins, fulvestrant, or to any of the excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675231


Locations
Hide Hide 93 study locations
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United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St Jude Medical Center
Fullerton, California, United States, 92835
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, United States, 90024
USC Norris Cancer Hospital
Los Angeles, California, United States, 90033
UCLA Medical Center
Los Angeles, California, United States, 90095
Cancer Care Associates Medical Group
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Monica, California, United States, 93454
United States, Colorado
Catholic Health Initiatives (CHI)
Englewood, Colorado, United States, 80112
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Florida Cancer Specialists
Fort Myers, Florida, United States, 33908
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
University of Miami Plantation
Plantation, Florida, United States, 33324
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Winship Cancer Center Emory University
Atlanta, Georgia, United States, 30322
Northside Hospital Cancer Institute
Atlanta, Georgia, United States, 30342
United States, Indiana
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana, United States, 46845
United States, Kentucky
St Joseph Cancer Center
Lexington, Kentucky, United States, 40509
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Montana
Billings Clinic Research Center
Billings, Montana, United States, 59101
United States, New York
Brookdale Hospital Medical Center
Brooklyn, New York, United States, 11212
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
Clinical Research Alliance, Inc
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
United States, Washington
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States, 98372
Swedish Medical Center
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Argentina
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Buenos Aires, Argentina, 1426
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Caba, Argentina, 1025
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Cordoba, Argentina, X5000JHGQ
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Cordoba, Argentina, X5000JHQ
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La Rioja, Argentina, 5300
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Rosario, Argentina, 2000
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Rosario, Argentina, S2000DSV
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San Miguel De Tucuman, Argentina, T4000IAK
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Viedma, Argentina, 8500
Australia
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Kurralta Park, Australia, 5037
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Nedlands, Australia, 6009
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St. Leonards, Australia, 2065
Belgium
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, Belgium, 3000
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Namur, Belgium, 5000
Brazil
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Porto Alegre, Brazil, 90610-000
Instituto COI de Pesquisa Educação e Gestão
Rio de Janeiro, Brazil, 22793-080
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Sao Paulo, Brazil, 05651-901
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São Paulo, Brazil, 01308-050
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo, Brazil, 01509-900
Canada
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Calgary, Canada, T2N 4N2
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Calgary, Canada, t2n42n
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Newmarket, Canada, L3Y2P9
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Ottawa, Canada, K1H 8L6
France
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Angers, France, 49055
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Besancon, France, 25030
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Lyon, France, 69373
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Montpellier, France, 34298
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Nice, France, 06189
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Paris, France, 75248
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Saint Cloud, France, 92210
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Villejuif, France, 94805
Germany
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Frankfurt am Main, Germany, 60431
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Freiburg, Germany, 79106
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Hamburg, Germany, 22087
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München, Germany, 81675
Greece
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Achaia, Greece, 26504
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Athens, Greece, 115 28
Italy
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Genova, Italy, 16132
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Milano, Italy, 20132
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Sora, Italy, 03039
Korea, Republic of
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Daegu, Korea, Republic of, 41404
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Goyang-si, Korea, Republic of, 10408
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 02841
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06351
Mexico
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Mexico City, Mexico, 14050
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Mexico, Mexico, 06700
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México City, Mexico, 03310
Spain
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Badajoz, Spain, 06080
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Barcelona, Spain, 08035
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Madrid, Spain, 28034
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Madrid, Spain, 28040
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Sevilla, Spain, 41013
United Kingdom
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Leicester, United Kingdom, LE1 5WN
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Manchester, United Kingdom, M20 4BX
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Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02675231    
Other Study ID Numbers: 15804
I3Y-MC-JPBZ ( Other Identifier: Eli Lilly and Company )
2015-003400-24 ( EudraCT Number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Fulvestrant
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs