A Study of LY2523355 in Participants With Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: LY2523355; ixabepilone; pegfilgrastim; filgrastim
Intervention description: Administered intravenously as a one hour infusion; Administered intravenously; Administered intravenously; Administered intravenously
Intervention MeSH terms: Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally; Recurrent; Breast; Cancer

Summary:

      The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to
      ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change
      in tumor size as a continuous measure of response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologic or cytologic diagnosis of metastatic or locally recurrent breast
             cancer that is not amenable to therapy given with curative intent.

          -  Have measurable disease defined by Response Evaluation Criteria In Solid Tumors
             (RECIST) 1.1 guidelines.

          -  Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic
             breast cancer and be, in the opinion of the investigator, an appropriate candidate for
             experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not
             counted as prior regimens.

          -  Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.

          -  Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and
             radiation prior to study enrollment.

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale.

          -  Have adequate organ function.

        Exclusion Criteria:

          -  Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater
             (moderate or worse) peripheral neuropathy

          -  Have a second primary malignancy.

          -  Have symptomatic, untreated, or uncontrolled central nervous system metastases.

          -  Have received autologous stem cell transplant following high-dose chemotherapy.

          -  Have serious preexisting medical conditions that in the opinion of the investigator
             would preclude participation in this study.

          -  Have active symptomatic fungal, bacterial, and/or known viral infection including
             active human immunodeficiency virus (HIV) or viral hepatitis.

          -  Have previously received LY2523355 in another study investigating this agent or
             therapy with ixabepilone or an ixabepilone-containing regimen.

          -  Have a history of radiation therapy involving more than 25 percent of the bone marrow.

          -  Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on
             screening electrocardiogram (ECG).

          -  Have QRS widening of >120 msec on screening ECG.

          -  Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4
             inducer per the ixabepilone label.

          -  Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone
             label.