Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : LY2835219 + Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole)
INN of investigational material :
Therapeutic category code : 429 Other antitum
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer -Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease -Have postmenopausal status -Have either measurable disease or nonmeasurable bone-only disease -Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale -Have adequate organ function -Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy -Are able to swallow capsules
Exclusion criteria
Exclusion criteria: -Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis -Have inflammatory breast cancer -Have clinical evidence or a history of central nervous system (CNS) metastasis -Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer -Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment -Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer -Have received prior treatment with everolimus -Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded) -Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization -Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study -Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively -Have had major surgery within 14 days prior to randomization
Outcome results
None listed