Ensayos clínicos

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:

• 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