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Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00555152
First received: November 6, 2007
Last updated: October 22, 2015
Last verified: August 2014
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Ductal Breast Carcinoma in Situ
HER2-positive Breast Cancer
Interventions: Drug: lapatinib ditosylate
Other: placebo
Other: laboratory biomarker analysis

  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
Activated 1/17/2008 at Baylor College of Medicine (BCM), MD Anderson Cancer Center, Dana-Farber Cancer Institute, Mayo Clinic, Georgetown University & Walter Reed Army Medical Center; closed at BCM 3/8/2010, re-activated 9/19/2011 at MD Anderson, Dana-Farber Cancer Institute, Mayo Clinic & University of Alabama, Birmingham, closed 8/28/2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 22 participants were enrolled and randomized to 3 of 4 treatment arms; Two of the 4 initial arms were removed in the second period with one of those having no enrollment. Three participants were enrolled while the study was open at BCM, the other 19 were enrolled after the study was transferred to MD Anderson (second study period).

Reporting Groups
  Description
Arm I Lapatinib 1500 mg Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
Arm II Lapatinib 1000 mg Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
Arm III Lapatinib 750 mg Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
Arm IV Placebo Placebo orally once daily for 2-6 weeks until the time of surgery.

Participant Flow for 2 periods

Period 1:   Period Open at BCM: 1/17/08-3/8/10
    Arm I Lapatinib 1500 mg     Arm II Lapatinib 1000 mg     Arm III Lapatinib 750 mg     Arm IV Placebo  
STARTED     2     0 [1]   0     1  
COMPLETED     2     0     0     1  
NOT COMPLETED     0     0     0     0  
[1] Participants in initial and second study registration periods reported separately.

Period 2:   Transfer to MD Anderson: 9/19/11-8/28/14
    Arm I Lapatinib 1500 mg     Arm II Lapatinib 1000 mg     Arm III Lapatinib 750 mg     Arm IV Placebo  
STARTED     0 [1]   10     0     9  
COMPLETED     0     10     0     9  
NOT COMPLETED     0     0     0     0  
[1] Participants in initial and second study registration periods reported separately.



  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
Arm I Lapatinib 1500 mg Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
Arm II Lapatinib 1000 mg Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
Arm III Lapatinib 750 mg Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
Arm IV Placebo Placebo orally once daily for 2-6 weeks until the time of surgery.
Total Total of all reporting groups

Baseline Measures
    Arm I Lapatinib 1500 mg     Arm II Lapatinib 1000 mg     Arm III Lapatinib 750 mg     Arm IV Placebo     Total  
Number of Participants  
[units: participants]
  2     10     0     10     22  
Age  
[units: years]
Mean (Standard Deviation)
  46  (9.5)     51.7  (10.7)         52  (8.4)     51.3  (9.3)  
Gender  
[units: participants]
         
Female     2     10         10     22  
Male     0     0         0     0  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     0     1         2     3  
Not Hispanic or Latino     2     9         8     19  
Unknown or Not Reported     0     0         0     0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0         0     0  
Asian     0     1         0     1  
Native Hawaiian or Other Pacific Islander     0     0         0     0  
Black or African American     0     0         0     0  
White     2     9         9     20  
More than one race     0     0         0     0  
Unknown or Not Reported     0     0         1     1  
Region of Enrollment  
[units: participants]
         
United States     2     10         10     22  



  Outcome Measures
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1.  Primary:   Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS)   [ Time Frame: 2-6 weeks from baseline to surgery, up to 6 weeks ]

2.  Primary:   Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0   [ Time Frame: From baseline to 4-5 weeks after surgery ]

3.  Secondary:   Incidence of Ductal Carcinoma in Situ Remaining at Resection   [ Time Frame: 2-6 weeks from baseline to surgery, up to 6 weeks ]

4.  Secondary:   Biomarker Analysis of Proliferation Markers   [ Time Frame: 2-6 weeks from baseline to surgery, Up to 6 weeks ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Powel H. Brown, MD/Chair, Clinical Cancer Prevention
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00555152     History of Changes
Obsolete Identifiers: NCT00570453
Other Study ID Numbers: NCI-2009-00875
NCI-2009-00875 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2008-0086 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000573719
H-19895
P50CA058183 ( US NIH Grant/Contract Award Number )
P30CA016672 ( US NIH Grant/Contract Award Number )
Study First Received: November 6, 2007
Results First Received: July 24, 2015
Last Updated: October 22, 2015
Health Authority: United States: Food and Drug Administration