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Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269346
First Posted: January 4, 2011
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
Results First Submitted: October 26, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Eribulin Mesylate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 64 participants were screened for entry into the study, of these participants 12 were screen failures and 52 were enrolled into the study and received at least one dose of study treatment.

Reporting Groups
  Description
Eribulin Mesylate in Combination With Trastuzumab

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.


Participant Flow for 2 periods

Period 1:   Treatment Phase
    Eribulin Mesylate in Combination With Trastuzumab
STARTED   52 
Completed 6 Cycles   45 
COMPLETED   43 
NOT COMPLETED   9 
Disease progression                3 
Adverse Event                3 
Withdrawal by Subject                1 
Not specified                2 

Period 2:   Extension Phase
    Eribulin Mesylate in Combination With Trastuzumab
STARTED   43 [1] 
COMPLETED   0 
NOT COMPLETED   43 
Adverse Event                6 
Withdrawal by Subject                4 
Disease progression                22 
Physician decision or participant choice                9 
Clinical progression                1 
Started a prohibited con med                1 
[1] Out of 52 participants randomized, only 43 continued into the Extension Phase of the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all participants who received at least one dose of study drug.

Reporting Groups
  Description
Eribulin Mesylate in Combination With Trastuzumab

Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.


Baseline Measures
   Eribulin Mesylate in Combination With Trastuzumab 
Overall Participants Analyzed 
[Units: Participants]
 52 
Age 
[Units: Years]
Geometric Mean (Standard Deviation)
 58.7  (10.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      51  98.1% 
Male      1   1.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR ]

2.  Secondary:   Time to First Response   [ Time Frame: From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months ]

3.  Secondary:   Duration of Response (DOR)   [ Time Frame: Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months ]

4.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months ]

5.  Secondary:   Duration of Stable Disease (SD)   [ Time Frame: Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
phone: 1-888-422-4743
e-mail: esi_medinfo@eisai.com



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01269346     History of Changes
Other Study ID Numbers: E7389-A001-208
First Submitted: December 31, 2010
First Posted: January 4, 2011
Results First Submitted: October 26, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017