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

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: NCT00857714
Recruitment Status : Terminated (Terminated due to low accrual)
First Posted : March 9, 2009
Results First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):
Indiana University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Ductal Carcinoma in Situ
Intervention: Drug: lapatinib

  Participant Flow

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
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

  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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   0 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 63 [1] 
[1] Only one patient available; standard deviation cannot be calculated.
[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 

  Outcome Measures

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

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
No text entered.

  More Information

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

Responsible Party: Indiana University Identifier: NCT00857714     History of Changes
Other Study ID Numbers: 0812-11
First Submitted: March 6, 2009
First Posted: March 9, 2009
Results First Submitted: June 16, 2015
Results First Posted: July 8, 2015
Last Update Posted: July 8, 2015