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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: E7389

• Registration Number: NCT01432886
• Lead Sponsor: Eisai Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Study Start: 2011-10
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Results First Submitted: 2015-03-19
• Results First Submitted QC: 2015-03-19
• Results First Posted: 2015-03-30
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E7389	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicity (DLT)	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	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.