A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
NCT ID: NCT04031885
Last Updated: 2021-08-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
4 participants
INTERVENTIONAL
2019-08-14
2020-08-11
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 + Fulvestrant
150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
Abemaciclib
Administered orally
Fulvestrant
Administered IM
Standard Chemotherapy
Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.
Interventions
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Abemaciclib
Administered orally
Fulvestrant
Administered IM
Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have had at least one endocrine therapy
* Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study
* If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study
Exclusion Criteria
* Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy
* Participants must not have certain active infections including HIV or hepatitis
* Participants must not be pregnant or breastfeeding
* Participants must not have certain types of cancers or certain previous cancer treatments
* Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants
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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Scottsdale Healthcare Hospitals
Avondale, Arizona, United States
University of Arizona Cancer Center
Phoenix, Arizona, United States
Yuma Regional Cancer Center
Yuma, Arizona, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Compassionate Cancer Care Medical Group Inc
Corona, California, United States
Chan Soon- Shiong Institute for Medicine
Costa Mesa, California, United States
Chan Soon- Shiong Institute for Medicine
El Segundo, California, United States
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, United States
St. Joseph Heritage Healthcare
Fullerton, California, United States
Scripps Clinic
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, United States
Univ of California Irvine College of Medicine
Orange, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
Emad Ibrahim, MD, INC
Redlands, California, United States
Compassionate Cancer Care Medical Group Inc
Riverside, California, United States
University of California, Davis - Health Systems
Sacramento, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Millennium Oncology
Hollywood, Florida, United States
Ocala Oncology, P.A.
Ocala, Florida, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, United States
Cleveland Clinic of Florida
Weston, Florida, United States
Candler Medical Oncology Practice
Savannah, Georgia, United States
Tift Regional Health System Anita Stewart Oncology Center
Tifton, Georgia, United States
Kaiser Permanente Center for Health Research
Honolulu, Hawaii, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Touro Infirmary
New Orleans, Louisiana, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States
York Hospital
York Village, Maine, United States
Reliant Medical Group, Inc.
Worcester, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Baptist Cancer Center
Oxford, Mississippi, United States
St. Francis Medical Center
Grand Island, Nebraska, United States
Oncology Hematology West
Omaha, Nebraska, United States
OptumCare Cancer Care
Las Vegas, Nevada, United States
Carol Simon Cancer Center at Overlook Medical Center
Summit, New Jersey, United States
Brooklyn Methodist Hospital
Brooklyn, New York, United States
Weill Cornell Medical College
New York, New York, United States
SUNY At Stony Brook
Stony Brook, New York, United States
White Plains Hospital
White Plains, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Womens and Infants
Providence, Rhode Island, United States
Baptist Cancer Center
Memphis, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Oncology Consultants, P.A.
Houston, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Centro Integrado de Cancer del Sur, PSC
Coto Laurel, PR, Puerto Rico
Bella Vista Oncology Group
Mayagüez, PR, Puerto Rico
Ponce Medical School
Ponce, PR, Puerto Rico
Centro de Cancer de la Mujer
Ponce, PR, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, PR, Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Other Identifiers
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I3Y-MC-JPCU
Identifier Type: OTHER
Identifier Source: secondary_id
17320
Identifier Type: -
Identifier Source: org_study_id
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