A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
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|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|
|Actual Primary Completion Date :||August 2013|
|Actual 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.
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
|Kashiwa-shi, Chiba, Japan|
|Hidaka-shi, Saitama, Japan|
|Study Director:||Tadashi Nakanishi||Eisai Co., Ltd.|