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:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01432886
First received: September 12, 2011
Last updated: June 18, 2015
Last verified: May 2015
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.:

Primary Outcome Measures:
  • Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 74 Years
Genders 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
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: 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

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01432886     History of Changes
Other Study ID Numbers: E7389-J081-107
Study First Received: September 12, 2011
Results First Received: March 19, 2015
Last Updated: June 18, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Breast Cancer

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

ClinicalTrials.gov processed this record on August 26, 2015