Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
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 Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
-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
-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