Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Inclusion Criteria

• Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer

• Have radiologic evidence of disease progression or recurrence either

  • On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
  • On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer

• Must be deemed appropriate for treatment with ET

• If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression

• Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)

• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)

• Have adequate renal, hematologic, and hepatic organ function

• Must be able to swallow capsules/tablets

Exclusion Criteria

• Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
• Have symptomatic or untreated central nervous system metastasis
• Have received any systemic therapy between disease recurrence/progression and study screening
• Have received more than 1 line of therapy for advanced or metastatic disease.
• Have received prior chemotherapy for metastatic breast cancer (MBC)
• Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor