Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT01269346

First received: December 31, 2010

Last updated: November 14, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 31, 2010

Last Updated Date

November 14, 2012

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response rate (ORR) [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Defined as the proportion of subjects who have a best overall response of confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as determined by the investigator.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01269346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

Official Title ^ICMJE

A Phase 2, Multicenter, Single-Arm Study of Eribulin Mesylate With Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer

Brief Summary

This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2)positive breast cancer.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Eribulin Mesylate

Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.

Study Arm (s)

Experimental: Experimental 1

Intervention: Drug: Eribulin Mesylate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion criteria:

Age 18 years or older
Histologically or cytologically proven adenocarcinoma of the breast
Subjects who have locally recurrent or metastatic disease with at least one measurable lesion
HER2 positive as determined by score of 3+ on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions
Adequate renal function
Adequate bone marrow function
Adequate liver function
Adequate cardiac function

Key Exclusion criteria:

Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2+ breast cancer.
Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer
Prior exposure to > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2 mitoxantrone, > 90 mg/m2 idarubicin, or > 720 mg/m2 epirubicin
Inflammatory breast cancer
Prior history of hypertensive crisis or hypertensive encephalopathy
Clinically significant cardiovascular impairment
Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.
Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
History of bleeding diasthesis
Currently pregnant or breast-feeding.
Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade </= 2 before enrollment

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01269346

Other Study ID Numbers ^ICMJE

E7389-A001-208

Has Data Monitoring Committee

Not Provided

Responsible Party

Eisai Inc.

Study Sponsor ^ICMJE

Eisai Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jessica Rege, PhD

Eisai Inc.

Information Provided By

Eisai Inc.

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top