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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:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01432886
First received: September 12, 2011
Last updated: January 13, 2015
Last verified: December 2014
  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 subjects with Adverse Events [ Time Frame: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 23 months. ] [ Designated as safety issue: Yes ]
  • Number of subjects with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: May 2014 (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

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
Last Updated: January 13, 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
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015