A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib; Anastrozole; Letrozole; Placebo
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Letrozole; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 493.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MONARCH 3

Summary:

      The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors
      (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be
      randomized to abemaciclib or placebo in a 2:1 ratio.
    

Eligibility 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:

          -  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