Breast Cancer Clinical Trial

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

Summary

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care 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.

View Eligibility Criteria

Eligibility 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 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:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

237

Study ID:

NCT02675231

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 91 Locations for this study

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Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
St Jude Medical Center
Fullerton California, 92835, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles California, 90024, United States
USC Norris Cancer Hospital
Los Angeles California, 90033, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Cancer Care Associates Medical Group
Redondo Beach California, 90277, United States
Central Coast Medical Oncology Corporation
Santa Monica California, 93454, United States
Catholic Health Initiatives (CHI)
Englewood Colorado, 80112, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Florida Cancer Specialists
Fort Myers Florida, 33908, United States
MD Anderson Cancer Center Orlando
Orlando Florida, 32806, United States
University of Miami Plantation
Plantation Florida, 33324, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Winship Cancer Center Emory University
Atlanta Georgia, 30322, United States
Northside Hospital Cancer Institute
Atlanta Georgia, 30342, United States
Fort Wayne Medical Oncology & Hematology, Inc.
Fort Wayne Indiana, 46845, United States
St Joseph Cancer Center
Lexington Kentucky, 40509, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Mayo Clinic
Rochester Minnesota, 55902, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Billings Clinic Research Center
Billings Montana, 59101, United States
Brookdale Hospital Medical Center
Brooklyn New York, 11212, United States
North Shore Hematology Oncology Associates
East Setauket New York, 11733, United States
Clinical Research Alliance, Inc
Lake Success New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Pennsylvania Hospital
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Northwest Medical Specialties, PLLC
Puyallup Washington, 98372, United States
Swedish Medical Center
Seattle Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
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Buenos Aires , 1426, Argentina
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Caba , 1025, Argentina
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Cordoba , X5000, Argentina
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Cordoba , X5000, Argentina
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La Rioja , 5300, Argentina
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Rosario , 2000, Argentina
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Rosario , S2000, Argentina
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San Miguel De Tucuman , T4000, Argentina
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Viedma , 8500, Argentina
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Kurralta Park , 5037, Australia
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Nedlands , 6009, Australia
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St. Leonards , 2065, Australia
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Charleroi , 6000, Belgium
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Gent , 9000, Belgium
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven , 3000, Belgium
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Namur , 5000, Belgium
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Porto Alegre , 90610, Brazil
Instituto COI de Pesquisa Educação e Gestão
Rio de Janeiro , 22793, Brazil
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Sao Paulo , 05651, Brazil
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São Paulo , 01308, Brazil
Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
São Paulo , 01509, Brazil
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Calgary , T2N 4, Canada
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Calgary , t2n42, Canada
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Newmarket , L3Y2P, Canada
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Ottawa , K1H 8, Canada
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Angers , 49055, France
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Besancon , 25030, France
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Lyon , 69373, France
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Montpellier , 34298, France
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Nice , 06189, France
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Paris , 75248, France
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Saint Cloud , 92210, France
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Villejuif , 94805, France
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Frankfurt am Main , 60431, Germany
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Freiburg , 79106, Germany
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Hamburg , 22087, Germany
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München , 81675, Germany
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Achaia , 26504, Greece
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Athens , 115 2, Greece
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Genova , 16132, Italy
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Milano , 20132, Italy
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Sora , 03039, Italy
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Daegu , 41404, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Mexico City , 14050, Mexico
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Mexico , 06700, Mexico
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México City , 03310, Mexico
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Badajoz , 06080, Spain
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Barcelona , 08035, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Sevilla , 41013, Spain
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Leicester , LE1 5, United Kingdom
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Manchester , M20 4, United Kingdom
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Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

237

Study ID:

NCT02675231

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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