A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Stopped early · Phase 4
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04031885
- Run by
- Eli Lilly and Company
- People needed
- 4
- Starts
- 2019-08-14
- Expected to finish
- 2020-08-11
- Last updated by the study team
- 2021-08-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs
- 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
You may not qualify if…
- Participants must not have breast cancer that has spread to the brain if untreated and with symptoms
- 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
Where it is running
- 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
- Scottsdale Healthcare Hospitals — Avondale, Arizona, United States
Full record on ClinicalTrials.gov
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