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

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. Identifier: NCT00817531
Recruitment Status : Terminated (terminated due to futility after interim analysis)
First Posted : January 6, 2009
Results First Posted : July 17, 2012
Last Update Posted : August 31, 2012
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Baylor Breast Care Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Dasatinib

  Participant Flow

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
Dasatinib Patients took Dasatinib 100mg daily

Participant Flow:   Overall Study
STARTED   22 [1] 
COMPLETED   20 [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

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
Dasatinib Patients took Dasatinib 100mg daily

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   2 
[Units: Years]
Mean (Standard Deviation)
 48.5  (12.7) 
[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

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

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

Responsible Party: Baylor Breast Care Center Identifier: NCT00817531     History of Changes
Other Study ID Numbers: H 21592
First Submitted: January 5, 2009
First Posted: January 6, 2009
Results First Submitted: May 7, 2012
Results First Posted: July 17, 2012
Last Update Posted: August 31, 2012