A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:June 10, 2014
End Date:October 22, 2018

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A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

The main purpose of this study is to evaluate whether the study drug known as abemaciclib is
effective in treating participants with breast cancer who have already tried other drug
treatments.


Inclusion Criteria.

- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor
Receptor 2 Negative (HER2-) breast cancer.

- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease
progression following anti-estrogen therapy.

- Prior treatment with at least 2 chemotherapy regimens:

- At least 1 of these regimens must have been administered in the metastatic
setting.

- At least 1 of these regimens must have contained a taxane.

- No more than 2 prior chemotherapy regimens in the metastatic setting.

- Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group
scale.

- Have discontinued all previous therapies for cancer.

- Have the presence of measureable disease as defined by Response Evaluation Criteria in
Solid Tumors Version 1.1.

Exclusion Criteria:

- Have either a history of central nervous system (CNS) metastasis or evidence of CNS
metastasis on the magnetic resonance image of brain obtained at baseline.

- Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6)
inhibitor.

- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of the initial dose of study drug.

- Have had major surgery within 14 days of the initial dose of study drug.

- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
in-situ of the cervix).
We found this trial at
28
sites
San Francisco, California 94143
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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Fort Myers, FL
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8940 N Kendall Dr # 300E
Miami, Florida 33176
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Miami, FL
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Austin, Texas 78731
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Austin, TX
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Bedford, Texas 76022
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Bedford, TX
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Brussel,
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cincinnati, OH
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Columbia, Maryland 21044
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Columbia, MD
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Dallas, Texas 75231
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Dallas, TX
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Denver, Colorado 80218
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Denver, CO
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Fort Worth, TX
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Houston, Texas 77024
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Houston, TX
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Minneapolis, Minnesota 55405
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Minneapolis, MN
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Nashville, Tennessee 37203
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
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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Plano, Texas 75093
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Plano, TX
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Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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Santa Barbara, California 93105
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Santa Barbara, CA
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Sedona, AZ
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Sherman, Texas 75090
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Sherman, TX
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The Woodlands, Texas 77380
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The Woodlands, TX
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Tucson, Arizona 85712
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Tyler, Texas 75702
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Tyler, TX
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Vancouver, Washington 98684
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Vancouver, WA
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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