Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 12, 2017
End Date:June 10, 2027

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A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

The purpose of this study is to evaluate the safety and efficacy of the study drug
abemaciclib in participants with high risk, node positive, early stage, hormone receptor
positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.


Inclusion Criteria:

- Women (regardless of menopausal status) or men ≥18 years of age (or per local
regulations).

- The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer
without evidence of distant metastases.

- The participant must have undergone definitive surgery of the primary breast tumor.

- The participant must have tumor tissue from breast (preferred) or lymph node for
exploratory biomarker analysis available prior to randomization.

- Pathologic lymph node involvement and at least one of the following indicating a
higher risk of recurrence:

- 4 or more positive axillary lymph nodes

- Tumor size of at least 5 centimeters

- Grade 3 defined as at least 8 points on the Bloom Richardson grading system

- Ki-67 index by central analysis of ≥20% on untreated breast tissue

- The participant must be randomized within 16 months from the time of definitive breast
cancer surgery.

- The participant may receive up to 12 weeks of endocrine therapy until randomization
following the last non-endocrine therapy (surgery, chemotherapy, or radiation)
whichever is last.

- Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and
radiotherapy and from surgical side effects following definitive breast surgery.

- Women of reproductive potential must have a negative blood pregnancy test and agree to
use highly effective contraceptive methods.

- The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

- The participant has adequate organ function.

- The participant is able to swallow oral medications.

Exclusion Criteria:

- Metastatic disease (including contralateral axillary lymph nodes) or node-negative
disease.

- Participants with inflammatory breast cancer.

- Participants with a history of previous breast cancer, with the exception of
ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5
years ago. Participants with a history of contralateral DCIS treated by local regional
therapy at any time may be eligible. Participants with a 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 5 years from the date of
randomization are excluded.

- Females who are pregnant or lactating.

- The participant has previously received treatment with any CDK4 and CDK6 inhibitor.

- The participant is receiving concurrent exogenous reproductive hormone therapy (for
example, birth control pills, hormone replacement therapy, or megestrol acetate).

- The participant has previously received endocrine therapy for breast cancer prevention
(tamoxifen or aromatase inhibitors) or raloxifene.

- The participant has serious preexisting medical condition(s) that, in the judgment of
the investigator, would preclude participation in this study.

- The participant has a personal history of any of the following conditions: syncope of
cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden
cardiac arrest. Any participant with a history of venous thromboembolism (VTE).

- The participant has active systemic infections or viral load.

- The participant has received an experimental treatment in a clinical trial within the
last 30 days or 5 half-lives, whichever is longer.
We found this trial at
158
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: James A. Reeves Jr.
Phone: 239-274-9930
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Carla Falkson
Phone: 205-975-2693
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Barbara B Haley
Phone: 214-648-4180
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Heather L McArthur
Phone: 310-967-2700
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Korman Research Pavilion%2c Suite 100
Philadelphia, Pennsylvania 19141
215-456-7215
Principal Investigator: Mark S Morginstin
Phone: 215-456-3880
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Kate Ida Lathrop
Phone: 2103587586
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Albany, New York 12206
Principal Investigator: Karen L Tedesco
Phone: 518-489-0044
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Amarillo, Texas 79106
Principal Investigator: Srini Reddy
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Anchorage, Alaska 99508
Principal Investigator: Jeanne E Anderson
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Arlington, Texas 76014
Principal Investigator: Scott L Fleischauer
Phone: 817-467-6092
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Athens, Georgia 30607
Principal Investigator: Petros G Nikolinakos
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Atlanta, Georgia 30341
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Austin, Texas 78731
Principal Investigator: Debra A Patt
Phone: 512-427-9400
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4950 Essen Lane
Baton Rouge, Louisiana 70809
Principal Investigator: Derrick W Spell
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Berazategui, Buenos Aires
Principal Investigator: Gladys Paz
Phone: 541142262013
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Bethesda, Maryland 20817
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
Principal Investigator: Hikaru Nakajima
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Beverly Hills, California 90211
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Sara M 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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Brewer, Maine 04412
Principal Investigator: Sarah Sinclair
Phone: 207-973-4249
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Burbank, California 91505
Principal Investigator: Raul R Mena
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Burlington, Vermont 05405
Principal Investigator: Peter A Kaufman
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Canton, Ohio 44710
Principal Investigator: Shruti Trehan
Phone: 330-438-6333
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4352 North Josey Lane
Carrollton, Texas 75010
Principal Investigator: Vibha T Thomas
Phone: 972-537-4143
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Cary, North Carolina 27511
Principal Investigator: Mark L Graham II
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Chattanooga, Tennessee 37404
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Chattanooga, Tennessee 37403
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Ruta D Rao
Phone: 312-942-5904
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, Illinois 60612
Principal Investigator: Thomas Lad
Phone: 312-864-7260
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Patrick J Ward
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Cleveland, Ohio 44194
Principal Investigator: Paula Silverman
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Columbus, Ohio 43215
Principal Investigator: Timothy D. Moore
Phone: 614-759-7740
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Daphne, Alabama 36526
Principal Investigator: Michael Meshad
Phone: 251-433-9899
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3720 South Interstate 35 East
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Principal Investigator: Sharad Jain
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
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Phone: 6262189200
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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1901 Grandview Avenue
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Neelima Denduluri
Phone: 703-208-9268
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph T Beck
Phone: 479-587-1700
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555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
Principal Investigator: Rajesh Bajaj
Phone: 843-777-7960
McLeod Regional Medical Center McLeod Health, a regional presence and predominant healthcare organization, is dedicated...
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Florham Park, New Jersey 07932
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Phone: 973-538-5210
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Fort Worth, Texas 76104
Principal Investigator: Chi M Pham
Phone: 817-850-2011
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Fredericksburg, Virginia 22401
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Phone: 540-371-0079
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Fresno, California 93720
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Phone: 559-326-1238
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12901 Bruce B Downs Boulevard
Gainesville, Florida 33612
Principal Investigator: Karen C Daily Weinstein
Phone: 352-273-7832
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Germantown, Tennessee 38138
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Gilbert, Arizona 85234
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Greenville, South Carolina 29607
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11110 Medical Campus Road
Hagerstown, Maryland 21742
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Harrisburg, Pennsylvania 17109
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Hendersonville, North Carolina 28791
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Hollywood, Florida 33024
Principal Investigator: Issac Levy
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Honolulu, Hawaii 96813
Principal Investigator: Kenneth Sumida
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Houma, Louisiana 70360
Principal Investigator: Genevieve Maronge
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Indianapolis, Indiana 46237
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Jackson, Mississippi 39202
Principal Investigator: Bobby L. Graham
Phone: 601-355-2485
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Jacksonville, Florida 32216
Principal Investigator: Alvaro Moreno-Aspitia
Phone: 904-953-2865
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Johnson City, New York 13790
Principal Investigator: Ronald P Harris
Phone: 607-763-6850
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Jonesboro, Arkansas 72401
Principal Investigator: Mazen Khalil
Phone: 870-207-8177
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Stephanie L Graff
Phone: 816-276-4700
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Kingsport, Tennessee 37660
Principal Investigator: Asheesh Shipstone
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Knoxville, Tennessee 37920
Principal Investigator: Timothy Panella
Phone: 865-544-9773
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Knoxville, Tennessee 37909
Principal Investigator: RAYMOND BRIG
Phone: 865-246-1958
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3500 South Lafountain Street
Kokomo, Indiana 46902
Principal Investigator: Annette Moore
Phone: 765-729-5948
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Stephani Christensen
Phone: 702-952-3400
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Bradley A Arrick
Phone: 603-650-7854
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lewiston, Maine 04240
Principal Investigator: Nicholette Erickson
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Loma Linda, California 92354
Principal Investigator: Gayathri Nagaraj
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Louisville, Kentucky 40202
Principal Investigator: Elizabeth Riley
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Marietta, Georgia 30060
Principal Investigator: Steven L McCune
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McAllen, Texas 78503
Principal Investigator: Alvaro Restrepo
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5236 West University Drive
McKinney, Texas 75071
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Medford, Oregon 97504
Principal Investigator: Aleksandra Sander
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Memphis, Tennessee 38120
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Mesquite, Texas 75150
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Minneapolis, Minnesota 55405
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Monterey, California 93940
Principal Investigator: Laura Stampleman
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Naperville, Illinois 60540
Principal Investigator: Alexander Hantel
Phone: 630-646-6047
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7274
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: Erika P Hamilton
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Andrea Silber
Phone: 203-734-1664
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10021
Principal Investigator: Eleni Andreopoulou
Phone: 646-962-9888
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Sarat Chandarlapaty
Phone: 212-639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
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Phone: 973-926-7231
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Niles, Illinois 60714
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Principal Investigator: Michael A Danso
Phone: 757-466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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2494 Southwest 19th Avenue Road
Ocala, Florida 34471
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Omaha, Nebraska 68114
Principal Investigator: Kirsten Leu
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Omaha, Nebraska 68124
Principal Investigator: Margaret Block
Phone: 402-691-6971
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Omaha, Nebraska 68106
Principal Investigator: Eric J Avery
Phone: 402-484-4900
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Omaha, Nebraska 68130
Principal Investigator: SMO NCCA National Cancer Care Alli
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Orange, California 92868
Principal Investigator: Stavroula Otis
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Paramus, New Jersey 07653
Principal Investigator: Thomas Rakowski
Phone: 201-634-5792
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Paris, Texas 75460
Principal Investigator: Sucharu Prakash
Phone: 903-785-0031
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Phoenix, Arizona
Principal Investigator: Donald W. Northfelt
Phone: 480-342-6059
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