Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00496808
First received: July 3, 2007
Last updated: April 19, 2012
Last verified: April 2012
Results First Received: June 27, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ductal Carcinoma In Situ
Intervention: Drug: Herceptin (Trastuzumab)

  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
Recruitment Period: March 2005 - November 2010. All recruitment was at UT MD Anderson Cancer Center.

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
Herceptin 8 mg/kg intravenously (IV) Over 90 Minutes

Participant Flow:   Overall Study
    Herceptin  
STARTED     69  
COMPLETED     69  
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
Herceptin 8 mg/kg intravenously (IV) Over 90 Minutes

Baseline Measures
    Herceptin  
Number of Participants  
[units: participants]
  69  
Age  
[units: years]
Median ( Full Range )
  53  
  ( 31 to 77 )  
Gender  
[units: participants]
 
Female     69  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     69  



  Outcome Measures
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1.  Primary:   Number of Participants Achieving Documented Change in Proliferation   [ Time Frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks ]

2.  Secondary:   Mean Percent of Ki-67   [ Time Frame: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks ]

3.  Primary:   Percent Change in Proliferation as Measured by Ki-67   [ Time Frame: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: David Welch, Manager, Clinical Protocol Administration
Organization: UT MD Anderson Cancer Center
e-mail: dwelch@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00496808     History of Changes
Other Study ID Numbers: 2004-0701
Study First Received: July 3, 2007
Results First Received: June 27, 2011
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board