Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer
|ClinicalTrials.gov Identifier: NCT00496366|
Recruitment Status : Terminated
First Posted : July 4, 2007
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Cancer Advanced Breast Cancer HER2/Neu-positive Breast Cancer||Drug: Capecitabine Drug: Lapatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in Patients With HER2/Neu-Overexpressing Advanced or Metastatic Breast Cancer|
|Actual Study Start Date :||July 23, 2007|
|Actual Primary Completion Date :||December 31, 2009|
|Actual Study Completion Date :||March 20, 2017|
Experimental: 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).
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).
Other Name: XelodaDrug: 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.
Other Name: Tykerb
- 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 ]
- -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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496366
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey at Hamilton|
|Hamilton, New Jersey, United States, 08690|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Deborah Toppmeyer, MD||Rutgers Cancer Institute of New Jersey|