Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 11, 2013
Last verified: November 2013

December 31, 2010
November 11, 2013
November 2010
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01269346 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
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.

Experimental: Experimental 1
Intervention: Drug: Eribulin Mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01269346
E7389-A001-208
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Jessica Rege, PhD Eisai Inc.
Eisai Inc.
November 2013

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