Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
