NIPH Clinical Trials Search

A Phase 1 study of Eribulin Mesylate with Trastuzumab.

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Breast Cancer
Date of first enrollment	13/09/2011
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : E7389 INN of investigational material : eribulin mesylate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Injection

Outcome(s)

Primary Outcome	To evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 74age old
Gender	Female
Include criteria	Females aged >-20 years and <75 years at the time of informed consent. Histologically or cytologically confirmed with breast cancer. Score 3+ by immunohistochemistry (IHC) or HER2 positive by FISH method. Subjects who meet any of the followings -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 breat 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.
Exclude criteria	Subjects with known brain metastasis accompanying clinical symptoms or requiring active treatment. Subjects with severe active infection requiring active treatent. 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 Beta-hCG test) or breastfeeding. Subjects judged to be ineligible for this study by the principal invesigator or subinvestigator.