A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:November 6, 2014
End Date:July 12, 2021

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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors
(NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be
randomized to abemaciclib or placebo in a 2:1 ratio.


Inclusion Criteria:

- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) breast cancer

- Have locoregionally recurrent disease not amenable to resection or radiation therapy
with curative intent or metastatic disease

- Have postmenopausal status

- Have either measurable disease or nonmeasurable bone-only disease

- Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale

- Have adequate organ function

- Have discontinued previous localized radiotherapy for palliative purposes or for lytic
lesions at risk of fracture prior to randomization and recovered from the acute
effects of therapy

- Are able to swallow capsules

Exclusion Criteria:

- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis

- Have inflammatory breast cancer

- Have clinical evidence or a history of central nervous system (CNS) metastasis

- Are currently receiving or have previously received endocrine therapy for
locoregionally recurrent or metastatic breast cancer

- Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12
months from completion of treatment

- Are currently receiving or have previously received chemotherapy for locoregionally
recurrent or metastatic breast cancer

- Have received prior treatment with everolimus

- Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or
participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is
still blinded)

- Have initiated bisphosphonates or approved receptor activator of nuclear factor
kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization

- Are currently receiving an investigational drug in a clinical trial or participating
in any other type of medical research judged not to be scientifically or medically
compatible with this study

- Have 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 had major surgery within 14 days prior to randomization
We found this trial at
37
sites
Rochester, Minnesota 55905
1524
mi
from 91732
Rochester, MN
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
2315
mi
from 91732
Fort Lauderdale, FL
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3525
Lakeland, Florida 33805
2161
mi
from 91732
Lakeland, FL
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
2433
mi
from 91732
New York, NY
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
2059
mi
from 91732
Augusta, GA
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Bakersfield, California 93309
105
mi
from 91732
Bakersfield, CA
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2277
mi
from 91732
Bethesda, MD
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7516
mi
from 91732
Camperdown,
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Chandler, Arizona 85224
356
mi
from 91732
Chandler, AZ
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1960
mi
from 91732
Columbus, OH
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Englewood, Colorado 80112
820
mi
from 91732
Englewood, CO
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Fayetteville, Arkansas 72703
1354
mi
from 91732
Fayetteville, AR
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209
mi
from 91732
Fresno, CA
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Fullerton, California 92835
14
mi
from 91732
Fullerton, CA
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Grand Island, Nebraska 68802
1174
mi
from 91732
Grand Island, NE
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Grand Junction, Colorado 81501
627
mi
from 91732
Grand Junction, CO
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Indianapolis, Indiana 46237
1793
mi
from 91732
Indianapolis, IN
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Johnson City, New York 13790
2328
mi
from 91732
Johnson City, NY
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Knoxville, Tennessee 37920
1925
mi
from 91732
Knoxville, TN
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
206
mi
from 91732
Las Vegas, NV
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Lincoln, Nebraska 68506
1256
mi
from 91732
Lincoln, NE
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24
mi
from 91732
Los Angeles, CA
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
24
mi
from 91732
Los Angeles, CA
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Lubbock, Texas 79410
924
mi
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Lubbock, TX
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Metairie, Louisiana 70006
1647
mi
from 91732
Metairie, LA
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Miami Lakes, Florida 33014
2311
mi
from 91732
Miami Lakes, FL
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Muncie, Indiana 47303
1835
mi
from 91732
Muncie, IN
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Northridge, California 91328
25
mi
from 91732
Northridge, CA
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Orlando, Florida 32804
2182
mi
from 91732
Orlando, FL
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500 Northeast Multnomah Street
Portland, Oregon 97227
828
mi
from 91732
Portland, OR
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Round Rock, Texas 78665
1213
mi
from 91732
Round Rock, TX
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Santa Monica, California 93454
138
mi
from 91732
Santa Monica, CA
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Savannah, Georgia 31405
2129
mi
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Savannah, GA
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1218
mi
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Temple, TX
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Tucson, Arizona 85715
426
mi
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Tucson, AZ
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Valley, Washington 99216
940
mi
from 91732
Valley, WA
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