Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast

This study has been terminated.
(Terminated due to low accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00857714
First received: March 6, 2009
Last updated: June 16, 2015
Last verified: June 2015
Results First Received: June 16, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Ductal Carcinoma in Situ
Intervention: Drug: lapatinib

  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
Thirty patients were expected for this trial but it stopped at one patient due to difficulty with recruitment.

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
1500 mg Lapatinib for 14-21 Days Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.

Participant Flow:   Overall Study
    1500 mg Lapatinib for 14-21 Days  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  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
1500 mg Lapatinib for 14-21 Days Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.

Baseline Measures
    1500 mg Lapatinib for 14-21 Days  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  63  (NA) [1]
Gender  
[units: participants]
 
Female     1  
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     0  
White     1  
More than one race     0  
Unknown or Not Reported     0  
[1] Only one patient available; standard deviation cannot be calculated.



  Outcome Measures
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1.  Primary:   Number of Patients Where Gene Signature Was Obtained.   [ Time Frame: Up to 60 days ]

2.  Secondary:   Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.   [ Time Frame: Up to 60 days ]


  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: Sunil Badve, MD
Organization: IndianaU
phone: 317-491-6417
e-mail: sbadve@iupui.edu


No publications provided


Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00857714     History of Changes
Other Study ID Numbers: 0812-11
Study First Received: March 6, 2009
Results First Received: June 16, 2015
Last Updated: June 16, 2015
Health Authority: United States: Food and Drug Administration