Status:
TERMINATED
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04031885
Start Date
August 14 2019
End Date
August 11 2020
Last Update
August 24 2021
Active Locations (61)
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1
Scottsdale Healthcare Hospitals
Avondale, Arizona, United States, 85392
2
University of Arizona Cancer Center
Phoenix, Arizona, United States, 85004
3
Yuma Regional Cancer Center
Yuma, Arizona, United States, 85364
4
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205