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A 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 study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01268150
First received: December 28, 2010
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.


Condition Intervention Phase
Locally Recurrent or Metastatic Breast Cancer ( HER2 Negative)
Drug: 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 Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: six 21-day cycles or discontinuation whichever is first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the incidence of adverse events of eribulin mesylate [ Time Frame: from Baseline until End of Treatment (within 21 days of last dose) ] [ Designated as safety issue: Yes ]
  • To assess time to first response [ Time Frame: from date of first dose to first date of confirmed objective response (CR or PR) ] [ Designated as safety issue: No ]
  • To assess duration of response [ Time Frame: from date of objective response (CR or PR) to the date of progressive disease or death ] [ Designated as safety issue: No ]
  • To assess progression-free survival (PFS) [ Time Frame: from first dose to date of progressive disease or death whichever is first ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: November 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: Drug: Eribulin mesylate
Eribulin mesylate 1.4 mg/m2 will be administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Detailed Description:

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).

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268150

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Augusta Oncology Associates
Augusta, Georgia, United States, 30901
Central Georgia Cancer Care
Macon, Georgia, United States, 31088
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
United States, Montana
Hematology Oncology Centers of Northern Rockies
Billings, Montana, United States, 59101
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Weill Cornell Medical Center
New York, New York, United States, 10021
United States, Oregon
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97225
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Oncology- Bedford
Bedford, Texas, United States, 76022
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75230-2510
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology- Tyler
Tyler, Texas, United States, 75702
United States, Washington
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States, 99336
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: David Cox Eisai Inc.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01268150     History of Changes
Other Study ID Numbers: E7389-A001-206
Study First Received: December 28, 2010
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014