Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

Inclusion Criteria:

Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
Prior chemotherapy is permitted with no limit on the number of prior regimens
Two weeks or more have elapsed since last chemotherapy or radiation treatment
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
Is female, ≥ 18 yrs of age
Protocol defined appropriate laboratory values
Negative pregnancy test within 7 calendar days prior to registration
Has signed a patient informed consent

Exclusion Criteria:

Had prior treatment with ixabepilone or other epothilones
Has HER2+ disease
Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
Has peripheral neuropathy > Grade 1
Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
Is pregnant or breast feeding