A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
This study is currently recruiting participants.
Verified October 2012 by Eisai Inc.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: September 12, 2011
Last updated: October 15, 2012
Last verified: October 2012
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.
|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:
U.S. FDA Resources
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Evaluation of dose limiting toxicity (DLT) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]To evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432886
|Contact: Customer Joy Department. EJ||_ML_CLNCL@hhc.eisai.co.jp|
|Kashiwa-shi, Chiba, Japan|
|Hidaka-shi, Saitama, Japan|
Sponsors and Collaborators
Eisai Co., Ltd.
|Study Director:||Tadashi Nakanishi||Eisai Co., Ltd.|