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A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432886
First Posted: September 13, 2011
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.

Condition Intervention Phase
Breast Cancer Drug: E7389 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 3 weeks ]
    For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.

  • Number of Participants With Adverse Events [ Time Frame: From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years ]
    The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.


Enrollment: 12
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7389
Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
  • Histologically or cytologically confirmed with breast cancer
  • Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method
  • Subjects who meet any of the following criteria:

    • Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
    • Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
    • Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1
  • Subjects who have submitted written informed consent for study entry

Exclusion Criteria

  • Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
  • Subjects with severe active infection requiring active treatment
  • Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
  • Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
  • Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
  • Subjects who are pregnant (positive B-hCG test) or breastfeeding
  • Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432886


Locations
Japan
Kashiwa-shi, Chiba, Japan
Hidaka-shi, Saitama, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Tadashi Nakanishi Eisai Co., Ltd.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01432886     History of Changes
Other Study ID Numbers: E7389-J081-107
First Submitted: September 12, 2011
First Posted: September 13, 2011
Results First Submitted: March 19, 2015
Results First Posted: March 30, 2015
Last Update Posted: October 7, 2016
Last Verified: August 2016

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Mitogens
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action