A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

This is a multicenter, single-arm, Phase 2 trial to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2)-negative breast cancer. A total of 52 adult female subjects will be enrolled and treated with eribulin mesylate (1.4 mg/m2 as an intravenous \[i.v.\] infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle).

Age

18–any

Sex

FEMALE

Healthy volunteers

Not accepted

You may be eligible if

Females age 18 years or older at the time of informed consent
Have histologically or cytologically proven adenocarcinoma of the breast
Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors
(RECIST) criteria v 1.1
Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.
Life expectancy of greater than 24 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions
Adequate renal function
Adequate bone marrow function
Adequate liver function

You may not be if

Subjects who meet any of the following criteria will be excluded from participation in this study:
Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer
Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer
Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin
Inflammatory breast cancer
Clinically significant cardiovascular impairment
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
Currently pregnant or breast-feeding.
Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.

What this study is about