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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: E7389


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: E7389<br>* Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Dose Limiting Toxicity (DLT) | For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle. | Up to 3 weeks | 
| Number of Participants With Adverse Events | The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated. | From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer