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Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients

This study has been terminated.
(terminated due to futility after interim analysis)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00817531
First received: January 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
Results First Received: May 7, 2012  
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: Dasatinib

  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
The study started recruitment in December 2010. Baylor college of Medicine is the only site of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
each patient have to be eligible and pass all screening tests after signing the consent to be enrolled in the study.

Reporting Groups
  Description
Dasatinib Patients took Dasatinib 100mg daily

Participant Flow:   Overall Study
    Dasatinib
STARTED   22 [1] 
COMPLETED   20 [2] 
NOT COMPLETED   2 
Adverse Event                1 
Lack of Efficacy                1 
[1] 22 patients were eligible for this study and started the treatment.
[2] 20 out of 22 patients finished study treatment. 2 patients stopped the treatment after the 1st week.



  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.
No text entered.

Reporting Groups
  Description
Dasatinib Patients took Dasatinib 100mg daily

Baseline Measures
    Dasatinib
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.5  (12.7) 
Gender 
[Units: Participants]
 
Female   22 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   22 


  Outcome Measures

1.  Primary:   Clinical Efficacy   [ Time Frame: Assessment at pre-surgery or 3 to 4 weeks of 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
The study was terminated after internal analysis due to treatment futility. It does not meet the required number of responses to continue the study.


  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: Dr. Mothaffar Rimawi
Organization: Baylor College of Medicine
phone: 713-798-1311
e-mail: rimawi@bcm.edu



Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00817531     History of Changes
Other Study ID Numbers: H 21592
Study First Received: January 5, 2009
Results First Received: May 7, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration