Clinical trial NCT01269346: Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
Official title: A Phase 2, Multicenter, Single-Arm Study of Eribulin Mesylate With Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Locally recurrent
metastatic HER2Positive breast cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion criteria:

* Age 18 years or older
* 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

Key Exclusion criteria:

* Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.
* 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 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
Secondary outcomes:
measure: Time to First Response
timeFrame: 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
measure: Duration of Response (DOR)
timeFrame: 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
measure: Progression-Free Survival (PFS)
timeFrame: 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
measure: Duration of Stable Disease (SD)
timeFrame: 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
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Davie
country: United States
facility: Florida Cancer Care
state: Florida
city: Jacksonville
country: United States
facility: Florida Oncology Associates
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology Oncology Associates, PC
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Saint Joseph
country: United States
facility: Heartland Regional Medical Center
state: Missouri
city: New York
country: United States
facility: Weill Cornell Breast Clinic
state: New York
city: Raleigh
country: United States
facility: Raleigh Hematology Associates
state: North Carolina
city: Bend
country: United States
facility: Cancer Care of the Cascades
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyoming Valley, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology/Oncology
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Germantown
country: United States
facility: C. Michael Jones, MD
state: Tennessee
city: Beaumont
country: United States
facility: Texas Oncology - Beaumont Marnie McFaddin Ward Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: El Paso
country: United States
facility: Texas Oncology - El Paso Cancer Treatment Center Grandview
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Memorial City
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen South Second Street
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Sherman
country: United States
facility: Texas Oncology - Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology - Sugar Land
state: Texas
city: Newport News
country: United States
facility: Pensisula Cancer Institute
state: Virginia
city: Kennewick
country: United States
facility: Columbia Basin Hematology and Oncology
state: Washington
Study officials:
affiliation: Eisai Inc.
name: Sam Misir
role: STUDY_DIRECTOR
References: