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

Eisai

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Treatments

Drug: E7389

Study type

Interventional

Funder types

Industry

Identifiers

NCT01432886

E7389-J081-107

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Female

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.