A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2018
Start Date:August 2015
End Date:January 2018

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Trial Summary
Trial Overview
Inclusion Criteria

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

The purpose of this study is to evaluate the biological effects of abemaciclib in combination
with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone
in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal
growth factor receptor 2 (HER2) negative breast cancer.


Inclusion Criteria:

- Have postmenopausal status.

- Adenocarcinoma of the breast.

- Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.

- Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.

- Primary breast cancer that is suitable for baseline core biopsy.

- Have adequate organ function.

Exclusion Criteria:

- Bilateral invasive breast cancer.

- Metastatic breast cancer (local spread to axillary lymph nodes is permitted).

- Inflammatory breast cancer.

- Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in
the same breast as currently being treated.

- Prior radiotherapy to the ipsilateral chest wall for any malignancy.

- Prior anti-estrogen therapy.
We found this trial at
28
sites
SMO TRIO -Translational Research
Los Angeles, California 90024
Phone: 310-824-1934
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Holy Cross Hospital
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Zdenka Segota
Phone: 954-267-7700
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Fort Lauderdale, FL
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Orlando Health
24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Rebecca Moroose
Phone: 321-841-2285
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Orlando, FL
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Northeast Georgia Cancer Care
Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos
Phone: 706-353-2990
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Athens, GA
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Augusta University
1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Principal Investigator: Shou-Ching Tang
Phone: 706-721-2505
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Comprehensive Blood and Cancer Center
Bakersfield, California 93309
Principal Investigator: Ravi Patel
Phone: 661-322-2206
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Bakersfield, CA
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St. Charles Health System
Bend, Oregon 97701
Principal Investigator: Robert Boone
Phone: 541-706-3732
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Bend, OR
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Walter Reed National Military Medical Center
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Jeremy Perkins
Phone: 301-369-8675
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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SMO Pharmatech Oncology Inc
Denver, Colorado 80203
Principal Investigator: Matthew Wiener
Phone: 303-475-5599
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Denver, CO
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West Clinic
Germantown, Tennessee 38138
Principal Investigator: Gregory Vidal
Phone: 901-683-0055
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Germantown, TN
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St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado 81501
Principal Investigator: Mark Levandovsky
Phone: 970-244-7164
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Grand Junction, CO
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Clinical Trial Facility in Graz
Graz, 77845
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
Principal Investigator: Aurelio Castrellon
Phone: 954-844-6898
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Hollywood, FL
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Kaiser Foundation Hospitals
Honolulu, Hawaii 96819
Principal Investigator: Jennifer Carney
Phone: 808-432-8594
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Honolulu, HI
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Millennium Oncology
Houston, Texas 77090
Principal Investigator: Mary Crow
Phone: 281-440-5006
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Houston, TX
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Kadlec Hematology & Oncology
7360 W. Deschutes
Kennewick, Washington 99336
509-783-0144
Principal Investigator: Eric Gamboa
Phone: 509-783-4637
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Teresa Helsten
Phone: 858-822-6195
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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Nebraska Hematology-Oncology, PC
Lincoln, Nebraska 68506
Principal Investigator: Eric Avery
Phone: 402-484-4900
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Lincoln, NE
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UCLA Medical Center
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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Oncology and Radiation Associates
Miami, Florida 33133
Principal Investigator: Mary Villar
Phone: 305-285-0726
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Miami, FL
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Weill-Cornell Medical College
New York, New York 10021
Principal Investigator: Eleni Andreopoulou
Phone: 212-821-0654
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Florida Cancer Research Institute
Plantation, Florida
Principal Investigator: Elizabeth Tan-Chiu
Phone: 954-582-1850
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Cancer Care Associates Medical Group, Inc.
Redondo Beach, California 90277
Principal Investigator: David Chan
Phone: 310-750-3376
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Redondo Beach, CA
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Utah Cancer Specialists
Salt Lake City, Utah 84106
Principal Investigator: Stephen Kendall
Phone: 801-281-6864
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Salt Lake City, UT
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Sansum Medical Research Foundation
Santa Barbara, California 93105
Principal Investigator: Julie Taquchi
Phone: 805-898-3270
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Santa Barbara, CA
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Central Coast Medical Oncology Corporation
Santa Monica, California 93454
Principal Investigator: Robert Dichmann
Phone: 805-739-3724
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Stanford University
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Suleiman Massarweh
Phone: 650-724-8935
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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University of Massachusetts Medical Center
Worcester, Massachusetts 01655
Principal Investigator: Madhavi Toke
Phone: 508-334-1000
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