Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
Condition: Recurrent Breast Carcinoma; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eribulin Mesylate; Laboratory Biomarker Analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Halichondrin B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well eribulin mesylate works in treating patients with
      previously treated breast cancer that has spread to other places in the body. Drugs used in
      chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor
      cells, either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading.
    

Eligibility criteria:

        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 < 10 mm or lymph nodes < 15 mm in short axis) with rising serum CA15-3 or
                  CA 27.29 or CEA documented by two consecutive measurements taken at least 14 days
                  apart with the most recent measurement being within 42 days prior to
                  registration. The second CA 15-3 or CA 27.29 value must have at least a 20%
                  increase over the first and for CA 15-3 or CA27.29 be greater than or equal to 40
                  units/mL or for CEA be greater than or equal to 4 ng/mL

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Hemoglobin >= 10 g/dL

          -  Platelets >= 100,000/mm^3

          -  Creatinine =< 1.5 x upper limit of normal (ULN)

          -  Total bilirubin =< 1.5 x ULN

          -  Alkaline phosphatase =< 3.0 x ULN; up to 5 x ULN is acceptable if due to bone
             metastases in the absence of liver metastases

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x
             institutional upper limit of normal, unless due to liver metastases (=< 5 x ULN)

          -  Women of child-bearing potential (WOCBP) and men must agree to use adequate
             contraception (hormonal or barrier method of birth control or abstinence) prior to
             study entry and for the duration of study participation

          -  Life expectancy of > 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