A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
NCT ID: NCT02441946
Last Updated: 2020-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2015-08-31
2018-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abemaciclib + Anastrozole
Abemaciclib (150 milligrams \[mg\]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
Abemaciclib
Administered orally
Loperamide
Administered orally
Anastrozole
Administered orally
Abemaciclib
Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
Abemaciclib
Administered orally
Loperamide
Administered orally
Anastrozole
Administered orally
Anastrozole
Anastrozole (1 mg) is given orally QD for 2 weeks.
All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.
Abemaciclib
Administered orally
Loperamide
Administered orally
Anastrozole
Administered orally
Interventions
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Abemaciclib
Administered orally
Loperamide
Administered orally
Anastrozole
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Comprehensive Blood and Cancer Center
Bakersfield, California, United States
University of California-San Diego
La Jolla, California, United States
SMO TRIO -Translational Research
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Cancer Care Associates Medical Group
Redondo Beach, California, United States
Sansum Medical Research Foundation
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Monica, California, United States
Stanford University
Stanford, California, United States
SMO Pharmatech Oncology Inc
Denver, Colorado, United States
St Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
Memorial Regional Hospital/Joe Dimaggio Childrens Hospital
Hollywood, Florida, United States
Oncology and Radiation Associates
Miami, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
Florida Cancer Research Institute
Plantation, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Georgia Regents University
Augusta, Georgia, United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Nebraska Hematology-Oncology
Lincoln, Nebraska, United States
Weill Cornell Medical College
New York, New York, United States
St. Charles Health System
Bend, Oregon, United States
The West Clinic
Germantown, Tennessee, United States
Millennium Oncology
Houston, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Columbia Basin Hematology & Oncology
Kennewick, Washington, 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, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Edegem, , Belgium
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Hasselt, , Belgium
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Namur, , Belgium
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Yvoir, , Belgium
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Montreal, , Canada
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Ottawa, , Canada
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Berlin, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Freiburg im Breisgau, , Germany
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Fürth, , Germany
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Heidelberg, , Germany
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Ludwigsburg, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Piacenza, , Italy
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Daegu, , South Korea
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Gangnam-gu, , South Korea
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Seodaemun-gu, , South Korea
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Seongbuk-gu, , South Korea
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Seongnam, , South Korea
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Songpa-gu, , South Korea
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Ulsan, , South Korea
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Badajoz, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Changhua, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
Countries
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References
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Franzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Apr;192(2):457-462. doi: 10.1007/s10549-022-06525-3. Epub 2022 Jan 25.
Hurvitz SA, Martin M, Press MF, Chan D, Fernandez-Abad M, Petru E, Rostorfer R, Guarneri V, Huang CS, Barriga S, Wijayawardana S, Brahmachary M, Ebert PJ, Hossain A, Liu J, Abel A, Aggarwal A, Jansen VM, Slamon DJ. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020 Feb 1;26(3):566-580. doi: 10.1158/1078-0432.CCR-19-1425. Epub 2019 Oct 15.
Related Links
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Click here for more information about this study: A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
Other Identifiers
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I3Y-MC-JPBY
Identifier Type: OTHER
Identifier Source: secondary_id
2014-005486-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15805
Identifier Type: -
Identifier Source: org_study_id
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