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Brief Title: A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Official Title: A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases
Study ID: NCT04031885
Brief Summary: The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, 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, , Puerto Rico
Bella Vista Oncology Group, Mayaguez, , Puerto Rico
Ponce Medical School, Ponce, , Puerto Rico
Centro de Cancer de la Mujer, Ponce, , Puerto Rico
Clinical Research Puerto Rico, Inc., San Juan, , Puerto Rico
Fundacion de Investigacion de Diego, San Juan, , Puerto Rico
Name: 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)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR