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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa-shi, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E7389

Drug

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.

Primary outcomes

Number of Participants With Dose Limiting Toxicity (DLT)

Time frame: Up to 3 weeks

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.
Number of Participants With Adverse Events

Time frame: From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years

The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 13, 2011
Registry last updated: Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed