Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer

Inclusion Criteria

• Ability to provide written informed consent
• Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
• At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Patients must have baseline imaging within 30 days prior to the start of therapy and satisfy one of the following:
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• At least one non lymph node lesion of >= 1.0 cm or lymph node >= 1.5 cm in short axis by computerized tomography (CT) scan (CT scan thickness no greater than 5 mm which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
• Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
• Non-measurable disease by RECIST 1.1 criteria (includes bone only disease and lesions = 1,500/mm^3
• Hemoglobin >= 10 g/dL
• Platelets >= 100,000/mm^3
• Creatinine = 12 weeks

Exclusion Criteria

• Prior treatment with eribulin
• Plan to administer any other systemic antitumor including endocrine therapy except for following standard of care treatment:
• Trastuzumab at standard dosing human epidermal growth factor receptor 2 (HER2) positive tumors
• Denosumab or bisphosphonates to treat metastatic bone disease
• Plan to administer concurrent radiation therapy now or for progressive symptoms during treatment
• Patients with known central nervous system (CNS) metastases must have stable disease off steroids after treatment with surgery or radiation therapy
• Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
• Patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (creatinine clearance [CrCl] 30-50 mL/min) renal impairment
• Radiotherapy within 14 days of study treatment
• Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
• Treatment with any systemic chemotherapy or investigational agents within 3 weeks of the start of study treatment; endocrine treatment must be stopped prior to initiating study treatment; subjects must have recovered from toxicities of prior therapy
• Patients with peripheral neuropathy > grade 2 regardless of etiology
• Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)
• Concomitant severe or uncontrolled medical disease
• Significant psychiatric or neurologic disorder which would compromise participation in the study
• Pregnant or breast-feeding females