Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
NCT ID: NCT01269346
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2010-12-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Eribulin Mesylate
Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.
Interventions
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Eribulin Mesylate
Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven adenocarcinoma of the breast
* Subjects who have locally recurrent or metastatic disease with at least one measurable lesion
* HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2
* At least 12 months since prior neoadjuvant or adjuvant chemotherapy
* At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions
* Adequate renal function
* Adequate bone marrow function
* Adequate liver function
* Adequate cardiac function
Exclusion Criteria
* Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer
* Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin
* Inflammatory breast cancer
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Clinically significant cardiovascular impairment
* Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.
* Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)
* Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
* History of bleeding diasthesis
* Currently pregnant or breast-feeding.
* Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sam Misir
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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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
Peachtree Hematology Oncology Associates, PC
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Weill Cornell Breast Clinic
New York, New York, United States
Raleigh Hematology Associates
Raleigh, North Carolina, United States
Cancer Care of the Cascades
Bend, Oregon, United States
Medical Oncology Associates of Wyoming Valley, P.C.
Kingston, Pennsylvania, United States
Charleston Hematology/Oncology
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
C. Michael Jones, MD
Germantown, Tennessee, United States
Texas Oncology - Beaumont Marnie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
Texas Oncology - McAllen South Second Street
McAllen, Texas, United States
Cancer Care Centers of South Texas
San Antonio, 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
Countries
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Other Identifiers
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E7389-A001-208
Identifier Type: -
Identifier Source: org_study_id
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