Breast Cancer Clinical Trial

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

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Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

224

Study ID:

NCT02441946

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 64 Locations for this study

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Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
University of California-San Diego
La Jolla California, 92037, United States
SMO TRIO -Translational Research
Los Angeles California, 90024, United States
UCLA Medical Center
Los Angeles California, 90024, United States
Cancer Care Associates Medical Group
Redondo Beach California, 90277, United States
Sansum Medical Research Foundation
Santa Barbara California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Monica California, 93454, United States
Stanford University
Stanford California, 94305, United States
SMO Pharmatech Oncology Inc
Denver Colorado, 80203, United States
St Mary's Hospital Regional Cancer Center
Grand Junction Colorado, 81501, United States
Holy Cross Hospital Inc.
Fort Lauderdale Florida, 33308, United States
Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
Hollywood Florida, 33021, United States
Oncology and Radiation Associates
Miami Florida, 33133, United States
Orlando Health, Inc
Orlando Florida, 32806, United States
Florida Cancer Research Institute
Plantation Florida, 33324, United States
Northeast Georgia Cancer Care, LLC
Athens Georgia, 30607, United States
Georgia Regents University
Augusta Georgia, 30912, United States
Kaiser Foundation Hospitals
Honolulu Hawaii, 96819, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
University of Massachusetts Medical Center
Worcester Massachusetts, 80203, United States
Nebraska Hematology-Oncology
Lincoln Nebraska, 68506, United States
Weill Cornell Medical College
New York New York, 10021, United States
St. Charles Health System
Bend Oregon, 97701, United States
The West Clinic
Germantown Tennessee, 38138, United States
Millennium Oncology
Houston Texas, 77090, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Columbia Basin Hematology & Oncology
Kennewick Washington, 99336, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Graz , 8036, Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Innsbruck , 6020, Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Wien , 1090, Austria
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Edegem , 2650, Belgium
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Hasselt , 3500, Belgium
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Namur , 5000, Belgium
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Yvoir , 5530, Belgium
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Montreal , H4A 3, Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Ottawa , K1H 8, Canada
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Berlin , 13125, Germany
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Erlangen , 91054, Germany
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Essen , 45136, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Esslingen , 73730, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Freiburg , 79106, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Furth , 90766, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Heidelberg , 69120, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Ludwigsburg , 71640, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Tubingen , 72076, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Ulm , 89075, Germany
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Milano , 20141, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Piacenza , 29121, Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Daegu , 41404, Korea, Republic of
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Gangnam-gu , 06351, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Seodaemun-gu , 03722, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seongbuk-gu , 02841, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seongnam , 13496, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Songpa-gu , 05505, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Ulsan-si , 44033, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Maastricht , 6229 , Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Rotterdam , 3015 , Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Badajoz , 06080, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Lleida , 25198, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Madrid , 28034, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Malaga , 29010, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Changhua , 500, Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Taichung , 40447, Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Taipei , 100, Taiwan
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

224

Study ID:

NCT02441946

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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