A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
|ClinicalTrials.gov Identifier: NCT01432886|
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : March 30, 2015
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: E7389||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2011|
|Primary Completion Date :||August 2013|
|Study Completion Date :||December 2013|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432886
|Kashiwa-shi, Chiba, Japan|
|Hidaka-shi, Saitama, Japan|
|Study Director:||Tadashi Nakanishi||Eisai Co., Ltd.|