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
- Conditions
- Metastatic Breast Cancer ( HER2 Negative)Locally Recurrent
- Interventions
- Registration Number
- NCT01268150
- Lead Sponsor
- Eisai Inc.
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Eribulin mesylate -
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 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 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
- Secondary Outcome Measures
Name Time Method 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 Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.
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 Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.
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 PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.
Trial Locations
- Locations (17)
Northwest Georgia Oncology Centers, P.C.
🇺🇸Marietta, Georgia, United States
Augusta Oncology Associates
🇺🇸Augusta, Georgia, United States
Central Georgia Cancer Care
🇺🇸Macon, Georgia, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Northwest Cancer Specialists, P.C.
🇺🇸Portland, Oregon, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Texas Oncology- Bedford
🇺🇸Bedford, Texas, United States
Columbia Basin Hematology and Oncology
🇺🇸Kennewick, Washington, United States
Texas Oncology - Medical City Dallas
🇺🇸Dallas, Texas, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Texas Oncology- Tyler
🇺🇸Tyler, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Hematology Oncology Centers of Northern Rockies
🇺🇸Billings, Montana, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
University of Miami
🇺🇸Miami, Florida, United States