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Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01439282
First received: September 19, 2011
Last updated: May 11, 2016
Last verified: May 2016
Results First Received: May 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor Positive Tumor
Breast Cancer
Interventions: Drug: eribulin mesylate
Drug: capecitabine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.

Participant Flow:   Overall Study
    Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine     Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine  
STARTED     67     10  
COMPLETED     59     9  
NOT COMPLETED     8     1  
Adverse Event                 5                 0  
Withdrawal by Subject                 2                 0  
Not specified                 1                 1  



  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 eribulin mesylate plus capecitabine.

Reporting Groups
  Description
Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
Total Total of all reporting groups

Baseline Measures
    Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine     Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine     Total  
Number of Participants  
[units: participants]
  67     10     77  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     7     53  
>=65 years     21     3     24  
Gender  
[units: Participants]
     
Female     67     10     77  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%   [ Time Frame: 21-Day Cycle 1 through 21-Day Cycle 4 ]

2.  Secondary:   Use of Cold Cap for Alopecia   [ Time Frame: On the day of study drug infusion treatments during Cycles 1 through 4 ]

3.  Secondary:   Number of Patients With Adverse Events of 4 Cycles of Eribulin Plus Capecitabine in the Adjuvant Setting   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01439282     History of Changes
Other Study ID Numbers: E7389-A001-212
Study First Received: September 19, 2011
Results First Received: May 11, 2016
Last Updated: May 11, 2016
Health Authority: United States: Food and Drug Administration