Eribulin in HER2 Negative Metastatic BrCa
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eribulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is not a randomized trial rather participants are enrolled based on disease histology. Participants in each arm receive the same treatment regimen.
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic breast cancer

Summary:

      Improvements in outcomes with metastatic breast cancer (MBC) have been observed in the last
      30 years, however, overall prognosis remains poor with median survival of 2 to 3 years. Long
      term complete responses are observed only for a minority of MBC patients (2-5%) and MBC
      remains an incurable disease for most patients. Eribulin is a chemotherapy approved by the US
      FDA in November of 2010 to treat patients with MBC who have received at least two prior
      chemotherapy regimens. In this research study, the investigators are looking to see how well
      eribulin helps participants with MBC in an earlier-line setting. Eribulin works by
      interfering with cancer cell division, growth and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven invasive breast cancer, locally recurrent or
             metastatic, with at least one measureable lesion according to RECIST v1.1

          -  Hormone receptor positive or hormone receptor negative HER2-negative disease

          -  Up to one prior line of chemotherapy for advanced disease is allowed (discontinued at
             least 14 days prior to initiation of protocol therapy)

          -  Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable

          -  No limit on prior lines of endocrine therapy, but must be discontinued at least 7 days
             prior to initiation of protocol therapy

          -  Must have completed any prior radiotherapy at least 2 weeks prior to initiation of
             protocol therapy

          -  Must have recovered from reversible effects of prior therapies to no more than grade 1
             toxicity, with the exception of alopecia

          -  Agree to use adequate contraception for the duration of study participation

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Prior treatment with eribulin

          -  Prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer
             unless diagnosed and definitively treated at least 3 years before enrollment in this
             study

          -  Clinically significant cardiovascular impairment

          -  Active brain metastases or unevaluated neurologic symptoms suggestive of brain
             metastases

          -  Pulmonary dysfunction requiring the use of oxygen

          -  Prior organ allograft requiring immunosuppression

          -  HIV positive on combination antiretroviral therapy

          -  Pre-existing grade 3 or 4 neuropathy

          -  Hypersensitivity to halichondrin B or halichondrin B chemical derivative

          -  Uncontrolled intercurrent illness

          -  Inability to read in English