A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.

Inclusion Criteria

• Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.

• Histologically or cytologically confirmed with breast cancer

• Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method

• Subjects who meet any of the following criteria:

  • Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
  • Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
  • Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer

• Adequate organ function

• Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1

• Subjects who have submitted written informed consent for study entry

Exclusion Criteria

• Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
• Subjects with severe active infection requiring active treatment
• Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
• Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
• Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
• Subjects who are pregnant (positive B-hCG test) or breastfeeding
• Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.