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Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer

This study has been terminated.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00496366
First received: July 3, 2007
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: March 20, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
HER2/Neu-positive Breast Cancer
Interventions: Drug: Capecitabine
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
We are reporting results on 11 subjects enrolled, who were recruited from July 2007 through December 2009. Subjects were recruited through the Cancer Institute of New Jersey's Oncology Group and this study was closed pre-maturely due to slow accrual.

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
Capecitabine (Xeloda) + Lapatinib (Tykerb)

Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).

Lapatinib will be taken daily continuously for 21 days (Days 1- 21).

Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).

Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.


Participant Flow:   Overall Study
    Capecitabine (Xeloda) + Lapatinib (Tykerb)
STARTED   11 
COMPLETED   10 
NOT COMPLETED   1 
Death                1 



  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
Capecitabine (Xeloda) + Lapatinib (Tykerb)

Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).

Lapatinib will be taken daily continuously for 21 days (Days 1- 21).

Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).

Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken.


Baseline Measures
   Capecitabine (Xeloda) + Lapatinib (Tykerb) 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6  54.5% 
>=65 years      5  45.5% 
Age 
[Units: Years]
Median (Full Range)
 60.7 
 (39 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  18.2% 
Not Hispanic or Latino      9  81.8% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   9.1% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   9.1% 
White      9  81.8% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determine the Response Rate (as Determined by RECIST Criteria) of Capecitabine and Lapatinib as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer That Overexpress HER2.   [ Time Frame: 2 years ]

2.  Secondary:   -Determine the Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease for at Least 6 Months) of Capecitabine and Lapatinib. -Determine Time to Disease Progression After Treatment With Capecitabine and Lapatinib. -Evaluate Overall   [ Time Frame: 2 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Deborah Toppmeyer, MD
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-6789
e-mail: toopmede@cinj.rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00496366     History of Changes
Other Study ID Numbers: 040608
NJ 1106
0220070103 ( Other Identifier: IRB )
Study First Received: July 3, 2007
Results First Received: March 20, 2017
Last Updated: March 20, 2017