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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432886
• Other study ID #: E7389-J081-107
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2011
• Last updated: June 18, 2015
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• E7389
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes