A Phase 1 study of Eribulin Mesylate with Trastuzumab.

A Phase 1 study of Eribulin Mesylate with Trastuzumab for Advanced or Recurrent Human Epiderma Growth Factor Receptor 2-Positive (HER2+) Breast Cancer.

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221578

Enrollment

Registered

2011-09-13

Start date

2011-09-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

investigational material(s) Generic name etc : E7389 INN of investigational material : eribulin mesylate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
To evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026