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Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01269346
First received: December 31, 2010
Last updated: February 10, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Eribulin Mesylate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 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:
  • Time to First Response [ Time Frame: 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.

  • Duration of Response (DOR) [ Time Frame: 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.

  • Progression-Free Survival (PFS) [ Time Frame: 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) [ Time Frame: 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.


Enrollment: 52
Study Start Date: December 2010
Study Completion Date: May 2016
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269346

  Hide Study Locations
Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80204
United States, Florida
Florida Cancer Care
Davie, Florida, United States, 33328
Florida Oncology Associates
Jacksonville, Florida, United States, 32256
Ocala Oncology Center
Ocala, Florida, United States, 34471
United States, Georgia
Peachtree Hematology Oncology Associates, PC
Atlanta, Georgia, United States, 30309
Northwest Georgia Oncology Centers, P.C.
Marrieta, Georgia, United States, 30060
United States, Kentucky
Montgomery Cancer Center
Mt. Sterling, Kentucky, United States, 40353
United States, Mississippi
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
Heartland Regional Medical Center
St. Joseph, Missouri, United States, 64507
United States, New York
Weill Cornell Breast Clinic
New York, New York, United States, 10065
United States, North Carolina
Raleigh Hematology Associates
Raleigh, North Carolina, United States, 27607
United States, Oregon
Cancer Care of the Cascades
Bend, Oregon, United States, 97701
United States, Pennsylvania
Medical Oncology Associates of Wyoming Valley, P.C.
Kingston, Pennsylvania, United States, 18704
United States, South Carolina
Charleston Hematology/Oncology
Charleston, South Carolina, United States, 29403
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Tennessee
C. Michael Jones, MD
Germantown, Tennessee, United States, 38138
United States, Texas
Texas Oncology - Beaumont Marnie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702-1449
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75201
Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas, United States, 79902
Texas Oncology - Memorial City
Houston, Texas, United States, 77024
Texas Oncology - McAllen South Second Street
McAllen, Texas, United States, 78503
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology - Sherman
Sherman, Texas, United States, 75090
Texas Oncology - Sugar Land
Sugar Land, Texas, United States, 77479
United States, Virginia
Pensisula Cancer Institute
Newport News, Virginia, United States, 23601
United States, Washington
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States, 99336
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Sam Misir Eisai Inc.
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01269346     History of Changes
Other Study ID Numbers: E7389-A001-208
Study First Received: December 31, 2010
Results First Received: October 26, 2016
Last Updated: February 10, 2017

Keywords provided by Eisai Inc.:
Locally recurrent
metastatic HER2Positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017