Cabozantinib for Metastatic Triple Negative BrCa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara Tolaney, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01738438
First received: November 28, 2012
Last updated: July 18, 2016
Last verified: July 2016
Results First Received: May 27, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Cabozantinib

  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
Patients enrolled from January 2013 through June 2014.

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
Cabozantinib Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Cabozantinib  
STARTED     35  
COMPLETED     0 [1]
NOT COMPLETED     35  
Disease Progression                 32  
Adverse Event                 3  
[1] Since treatment was not of fixed duration, all participants were considered as 'Not Completed'.



  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.
The analysis dataset is comprised of all treated patients.

Reporting Groups
  Description
Cabozantinib Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Cabozantinib  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Median (Full Range)
  50  
  (31 to 78)  
Gender  
[units: participants]
 
Female     35  
Male     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     32  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     35  



  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17). ]

2.  Secondary:   Progression Free Survival   [ Time Frame: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17). ]

3.  Post-Hoc:   15-Week Clinical Benefit Rate   [ Time Frame: Disease was evaluated radiologically at baseline, week 6 and week 15 on treatment. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sara Tolaney, MD
Organization: Dana-Farber Cancer Institute
phone: 617.632.2335
e-mail: Sara_Tolaney@DFCI.HARVARD.EDU



Responsible Party: Sara Tolaney, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01738438     History of Changes
Other Study ID Numbers: 12-431
Study First Received: November 28, 2012
Results First Received: May 27, 2016
Last Updated: July 18, 2016
Health Authority: United States: Food and Drug Administration