A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib; Tamoxifen; Prophylactic Loperamide
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Tamoxifen; Loperamide; Antidiarrheals
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus
      tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive
      (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of HR+, HER2- breast cancer.

          -  Relapsed or progressed following endocrine therapy.

          -  Have received prior treatment with at least 2 chemotherapy regimens, of which at least
             1 but no more than 2 have been administered in the metastatic setting.

          -  Have the presence of measureable disease as defined by the Response Evaluation
             Criteria in Solid Tumors (RECIST 1.1).

          -  Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.

          -  Have discontinued previous therapies for cancer (including specifically, aromatase
             inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at
             least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents
             prior to receiving study drug, and recovered from the acute effects of therapy (until
             the toxicity resolves to either baseline or at least Grade 1) except for residual
             alopecia or peripheral neuropathy.

          -  Have adequate organ function.

          -  Have negative serum pregnancy test within 7 days prior to the first dose of study
             treatment and agree to use highly effective precautions to prevent pregnancy during
             the study and for 3 weeks following last dose of study treatment.

          -  Are able to swallow oral medication.

        Exclusion Criteria:

          -  Have clinical evidence or history of central nervous system metastasis.

          -  Have a personal history of any of the following conditions: syncope of either
             unexplained or cardiovascular etiology, ventricular tachycardia, ventricular
             fibrillation, or sudden cardiac arrest.

          -  Have active bacterial or fungal infection (that is, requiring intravenous antibiotics
             at the time of initiating study treatment) and/or detectable viral infection.

          -  Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6
             inhibitor.

          -  Have a preexisting chronic condition resulting in persistent diarrhea.

          -  Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma
             in-situ of the cervix or breast), unless in complete remission with no therapy for a
             minimum of 3 years.