A Phase 1 study of Eribulin Mesylate with Trastuzumab.
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2080221578
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 24
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method