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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Eribulin Mesylate
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 52
Study Start Date: November 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269346

  Show 26 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Jessica Rege, PhD Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01269346     History of Changes
Other Study ID Numbers: E7389-A001-208
Study First Received: December 31, 2010
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Locally recurrent or metastatic HER2Positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013