This trial is active, not recruiting.

Condition breast cancer
Treatment eribulin mesylate
Phase phase 2
Sponsor Eisai Inc.
Start date December 2010
End date March 2013
Trial size 52 participants
Trial identifier NCT01269346, E7389-A001-208


This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
eribulin mesylate
Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.

Primary Outcomes

Objective response rate (ORR)
time frame: 30 months

Eligibility Criteria

Female participants at least 18 years old.

Key Inclusion criteria: - Age 18 years or older - Histologically or cytologically proven adenocarcinoma of the breast - Subjects who have locally recurrent or metastatic disease with at least one measurable lesion - HER2 positive as determined by score of 3+ on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH). - Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2 - At least 12 months since prior neoadjuvant or adjuvant chemotherapy - At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions - Adequate renal function - Adequate bone marrow function - Adequate liver function - Adequate cardiac function Key Exclusion criteria: - Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2+ breast cancer. - Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer - Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin - Inflammatory breast cancer - Prior history of hypertensive crisis or hypertensive encephalopathy - Clinically significant cardiovascular impairment - Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis. - Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) - Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen - History of bleeding diasthesis - Currently pregnant or breast-feeding. - Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment

Additional Information

Official title A Phase 2, Multicenter, Single-Arm Study of Eribulin Mesylate With Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Eisai Inc..
Location data was received from the National Cancer Institute and was last updated in June 2016.