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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Locally Recurrent or Metatastic Breast Cancer ( HER2 Negative)

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Trial Information

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


This is a multicenter, single-arm, Phase 2 trial to assess the efficacy and safety of
single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent
or metastatic human epidermal growth factor receptor (HER2)-negative breast cancer. A total
of 52 adult female subjects will be enrolled and treated with eribulin mesylate (1.4 mg/m2
as an intravenous [i.v.] infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle).

Inclusion Criteria


Key Inclusion Criteria

Females age 18 years or older at the time of informed consent

Have histologically or cytologically proven adenocarcinoma of the breast

Subjects with locally recurrent or metastatic disease with at least one measurable lesion
according to Response Evaluation Criteria in Solid Tumors

(RECIST) criteria v 1.1

Human epidermal growth factor receptor (HER2)-negative disease as determined by
fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC)
staining.

Life expectancy of >24 weeks

Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2

At least 12 months since prior neoadjuvant or adjuvant chemotherapy

At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery
from the effects of these interventions

Adequate renal function

Adequate bone marrow function

Adequate liver function

Key Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in
this study:

Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or
metastatic breast cancer

Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or
nonmelanoma skin cancer

Prior exposure of >360 mg/m2 doxorubicin or liposomal doxorubicin, >120 mg/m2
mitoxantrone, >90 mg/m2 idarubicin, or >720 mg/m2 epirubicin

Inflammatory breast cancer

Clinically significant cardiovascular impairment

Subjects with known CNS disease are not eligible, except for those with treated brain
metastasis.

Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use
of oxygen

Currently pregnant or breast-feeding.

Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover
to Grade 2 before enrollment.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the objective response rate (ORR) after first-line treatment with single-agent eribulin mesylate in subjects with locally recurrent or metastatic HER2-negative breast cancer.

Outcome Time Frame:

six 21-day cycles or discontinuation whichever is first

Safety Issue:

No

Principal Investigator

David Cox

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7389-A001-206

NCT ID:

NCT01268150

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Locally Recurrent or Metatastic Breast Cancer ( HER2 Negative)
  • Breast Neoplasms

Name

Location

Missouri Cancer AssociatesColumbia, Missouri  65201
New York Oncology Hematology, P.C.Albany, New York  12208
Weill Cornell Medical CenterNew York, New York  10021
Augusta Oncology AssociatesAugusta, Georgia  30901
University of MiamiMiami, Florida  33136
Central Indiana Cancer CentersIndianapolis, Indiana  46227
The West ClinicMemphis, Tennessee  38120
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Northwest Cancer Specialists, P.C.Portland, Oregon  97227
Central Georgia Cancer CareMacon, Georgia  31201
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Texas Oncology-Dallas Presbyterian HospitalDallas, Texas  75231
Texas Oncology- BedfordBedford, Texas  
Texas Oncology - Medical City DallasDallas, Texas  
Hematology Oncology Centers of Northern RockiesBillings, Montana  59101
Texas Oncology- TylerTyler, Texas  75702