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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

Trial Status: Temporarily Closed to Accrual

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.

Inclusion 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

Exclusion Criteria

  • 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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: John Anthony Glaspy
Phone: 310-794-4955
Sacramento
University of California Davis Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nicole A Jenci
Phone: 913-945-8871

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Hadeel Assad
Phone: 313-578-4405

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Trial Phase Phase IV

Trial Type Treatment

Lead Organization
Eli Lilly and Company

  • Primary ID 17320
  • Secondary IDs NCI-2019-08420, I3Y-MC-JPCU
  • Clinicaltrials.gov ID NCT04031885