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

NCT01268150 | Completed Phase 2 Results

• 1 other identifier: E7389-A001-206
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Locally Recurrent; Metastatic Breast Cancer ( HER2 Negative)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR

  Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

Secondary Outcomes (3)

• Time to First Response (CR or PR)

  Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

• Duration of Response

  First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

• Progression-Free Survival (PFS)

  Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

Other Outcomes (1)

• To Assess the Incidence of Adverse Events (AEs) of Eribulin Mesylate

  Baseline until End of Treatment (within 21 days of last dose), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

Study Arms (1)

Experimental

EXPERIMENTAL

Drug: Eribulin mesylate

Interventions

Eribulin mesylate DRUG

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 greater than 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

You may not qualify if:

• 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 greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (17)

University of Miami

Miami, Florida, 33136, United States

Location

Augusta Oncology Associates

Augusta, Georgia, 30901, United States

Location

Central Georgia Cancer Care

Macon, Georgia, 31088, United States

Location

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, 30060, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Hematology Oncology Centers of Northern Rockies

Billings, Montana, 59101, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97225, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Texas Oncology- Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75230-2510, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Texas Oncology- Tyler

Tyler, Texas, 75702, United States

Location

Columbia Basin Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Related Publications (1)

• McIntyre K, O'Shaughnessy J, Schwartzberg L, Gluck S, Berrak E, Song JX, Cox D, Vahdat LT. Phase 2 study of eribulin mesylate as first-line therapy for locally recurrent or metastatic human epidermal growth factor receptor 2-negative breast cancer. Breast Cancer Res Treat. 2014 Jul;146(2):321-8. doi: 10.1007/s10549-014-2923-9. Epub 2014 Apr 4.

  PMID: 24699910 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai Inc.

1-888-422-4743

Study Officials

• Sam Misir

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2013
• Last Updated: June 22, 2023
• Results First Posted: August 9, 2016

Record last verified: 2016-06

Locations

US (17)