Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
- Registration Number
- NCT01269346
- Lead Sponsor
- Eisai Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Eribulin Mesylate -
- Primary Outcome Measures
Name Time Method Objective Response Rate Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.
Time to First Response From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months Time to first response was defined for participants whose best overall response was a CR or PR.
Progression-Free Survival (PFS) Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months 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.
Duration of Stable Disease (SD) Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months Defined as the period from treatment start date to the date of PD or death, whichever occurred first. Participants who were alive without having PD as of the data cutoff date were censored as of their last tumor assessment. Calculated for participants who best response was SD.
Trial Locations
- Locations (26)
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Texas Oncology - Medical City Dallas
🇺🇸Dallas, Texas, United States
Peachtree Hematology Oncology Associates, PC
🇺🇸Atlanta, Georgia, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Florida Cancer Care
🇺🇸Davie, Florida, United States
Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Jackson Oncology Associates, PLLC
🇺🇸Jackson, Mississippi, United States
Northwest Georgia Oncology Centers, P.C.
🇺🇸Marietta, Georgia, United States
Montgomery Cancer Center
🇺🇸Mount Sterling, Kentucky, United States
Raleigh Hematology Associates
🇺🇸Raleigh, North Carolina, United States
Medical Oncology Associates of Wyoming Valley, P.C.
🇺🇸Kingston, Pennsylvania, United States
Weill Cornell Breast Clinic
🇺🇸New York, New York, United States
Cancer Care of the Cascades
🇺🇸Bend, Oregon, United States
Charleston Hematology/Oncology
🇺🇸Charleston, South Carolina, United States
C. Michael Jones, MD
🇺🇸Germantown, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Grandview
🇺🇸El Paso, Texas, United States
Texas Oncology - Beaumont Marnie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Oncology - Memorial City
🇺🇸Houston, Texas, United States
Texas Oncology - Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology - Sugar Land
🇺🇸Sugar Land, Texas, United States
Pensisula Cancer Institute
🇺🇸Newport News, Virginia, United States
Columbia Basin Hematology and Oncology
🇺🇸Kennewick, Washington, United States
Texas Oncology - McAllen South Second Street
🇺🇸McAllen, Texas, United States