A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT02675231
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
237 participants
INTERVENTIONAL
2016-05-23
2023-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant
150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.
Abemaciclib
Administered Orally
Trastuzumab
Administered IV
Fulvestrant
Administered IM
150 mg Abemaciclib + 8 mg/kg Trastuzumab
150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.
Abemaciclib
Administered Orally
Trastuzumab
Administered IV
8 mg/kg Trastuzumab + Standard of Care Chemotherapy
8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg 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
Trastuzumab
Administered IV
Standard of Care Single Agent Chemotherapy
Standard-of-care single-agent chemotherapy of physician's choice administered according to product label
Interventions
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Abemaciclib
Administered Orally
Trastuzumab
Administered IV
Fulvestrant
Administered IM
Standard of Care Single Agent Chemotherapy
Standard-of-care single-agent chemotherapy of physician's choice administered according to product label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 due to surgical / natural menopause or chemical ovarian suppression
* 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 if 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
* 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
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Comprehensive Blood and Cancer Center
Bakersfield, California, United States
St Jude Medical Center
Fullerton, California, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, United States
USC Norris Cancer Hospital
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Cancer Care Associates Medical Group
Redondo Beach, California, United States
Central Coast Medical Oncology Corporation
Santa Monica, California, United States
Catholic Health Initiatives (CHI)
Englewood, Colorado, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
University of Miami Plantation
Plantation, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Winship Cancer Center Emory University
Atlanta, Georgia, United States
Northside Hospital Cancer Institute
Atlanta, Georgia, United States
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana, United States
St Joseph Cancer Center
Lexington, Kentucky, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Billings Clinic Research Center
Billings, Montana, United States
Brookdale Hospital Medical Center
Brooklyn, New York, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Clinical Research Alliance, Inc
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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La Rioja, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Viedma, , Argentina
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Kurralta Park, , Australia
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Nedlands, , Australia
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St Leonards, , Australia
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Charleroi, , Belgium
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Ghent, , Belgium
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, , Belgium
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Namur, , Belgium
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Porto Alegre, , Brazil
Instituto COI de Pesquisa Educação e Gestão
Rio de Janeiro, , Brazil
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São Paulo, , Brazil
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo, , Brazil
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São Paulo, , Brazil
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Calgary, , Canada
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Calgary, , Canada
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Newmarket, , Canada
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Ottawa, , Canada
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Angers, , France
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Besançon, , France
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Lyon, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Saint-Cloud, , France
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Villejuif, , France
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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München, , Germany
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Achaia, , Greece
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Athens, , Greece
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Genova, , Italy
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Milan, , Italy
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Sora, , Italy
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Mexico City, , Mexico
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México, , Mexico
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México, , Mexico
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Daegu, , South Korea
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Goyang-si, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badajoz, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Leicester, , United Kingdom
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Manchester, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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Tolaney SM, Goel S, Nadal J, Denys H, Borrego MR, Litchfield LM, Liu J, Appiah AK, Chen Y, Andre F. Overall Survival and Exploratory Biomarker Analyses of Abemaciclib plus Trastuzumab with or without Fulvestrant versus Trastuzumab plus Chemotherapy in HR+, HER2+ Metastatic Breast Cancer Patients. Clin Cancer Res. 2024 Jan 5;30(1):39-49. doi: 10.1158/1078-0432.CCR-23-1209.
Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, Andre F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)
Other Identifiers
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I3Y-MC-JPBZ
Identifier Type: OTHER
Identifier Source: secondary_id
2015-003400-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15804
Identifier Type: -
Identifier Source: org_study_id
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