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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:May 23, 2016
End Date:February 26, 2021

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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

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.


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
We found this trial at
32
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Maura Dickler
Phone: 646-888-4560
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1045 North 30th Street
Billings, Montana 59101
406-255-8470
Principal Investigator: Michael Kidd
Phone: 406-238-7330
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Billings, MT
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Lowell Hart
Phone: 239-274-9930
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Fort Myers, FL
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Principal Investigator: Sunil Babu
Phone: 317-436-0800
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Fort Wayne, IN
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
Principal Investigator: Regan Rostorfer
Phone: 321-841-1946
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Orlando, FL
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Lupe Salazar
Phone: 206-616-8503
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Atlanta, Georgia 30322
Principal Investigator: Jane Meisel
Phone: 404-778-1900
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Atlanta, GA
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Atlanta, Georgia 30341
Principal Investigator: Amelia Zelnak
Phone: 770-205-5292
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Bakersfield, California 93309
Principal Investigator: David Kanamori
Phone: 661-616-1619
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Sara Tolaney
Phone: 617-632-3800
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brooklyn, New York 11212
Principal Investigator: Vladimir Gotlieb
Phone: 718-240-6208
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East Setauket, New York 11733
Principal Investigator: Noshir DaCosta
Phone: 631-751-3000
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Englewood, Colorado 80112
Principal Investigator: SMO Catholic Health Oncology Netwo
Phone: 720-784-1304
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Fort Worth, Texas 76104
Principal Investigator: Robyn Young
Phone: 817-759-7023
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Fullerton, California 92835
Principal Investigator: William Lawler
Phone: 714-446-5804
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Lake Success, New York 11042
Principal Investigator: Francis Arena
Phone: 516-466-6611
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Lake Success, New York 11042
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Lexington, Kentucky 40509
Principal Investigator: Jessica Moss
Phone: 859-629-7123
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Los Angeles, California 90024
Phone: 310-824-1934
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1441 Eastlake Avenue
Los Angeles, California 90033
Principal Investigator: Janice Lu
Phone: 323-865-3962
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Sara Hurvitz
Phone: 310-829-5471
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-239-7615
Sarah Cannon Cancer Center People who live with cancer
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Denise Yardley
Phone: 615-340-2827
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Jennifer Matro
Phone: 215-662-7096
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Plantation, Florida 33324
Principal Investigator: Carmen Calfa
Phone: 954-210-1168
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Puyallup, Washington 98372
Principal Investigator: Sibel Blau
Phone: 253-428-8700
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Redondo Beach, California 90277
Principal Investigator: David Chan
Phone: 310-750-3376
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Rochester, Minnesota 55905
Principal Investigator: Ciara O'Sullivan
Phone: 507-284-8665
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Saint Petersburg, Florida 33705
Principal Investigator: Gail Shaw Wright
Phone: 727-216-1143
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Santa Monica, California 93454
Principal Investigator: Robert Dichmann
Phone: 805-346-3461
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Erin Ellis
Phone: 206-215-3086
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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