Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2
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|ClinicalTrials.gov Identifier: NCT00544804|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : July 2, 2014
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Cancer||Drug: lapatinib ditosylate Genetic: gene expression analysis Other: diagnostic laboratory biomarker analysis||Phase 1|
- To determine the maximum tolerated dose (MTD) of high-dose lapatinib ditosylate in patients with HER2-overexpressing advanced or metastatic breast cancer.
- To determine the dose-limiting toxicity of this drug in these patients.
- To determine whether tumor HER2 can be completely inactivated by lapatinib ditosylate at its MTD in the 5-day schedule.
- To determine whether the total inactivation of HER2 decreases cardiac ejection fraction.
OUTLINE: Patients are stratified according to dose level.
Patients receive escalating doses of oral lapatinib ditosylate twice daily on days 1-5 until the maximum tolerated dose is determined. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Some patients undergo tumor tissue and blood sample collection periodically for biological and correlative studies. Samples are analyzed for evidence of cardiac injury, tumor target lysis effects, and to determine if the lapatinib serum levels result in the inactivation of tumor HER2 and HER3 kinase and oncogenic signaling.
After completion of study treatment, patients are followed every 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer|
|Study Start Date :||August 2007|
|Primary Completion Date :||June 2013|
|Study Completion Date :||December 2013|
Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
|Drug: lapatinib ditosylate Genetic: gene expression analysis Other: diagnostic laboratory biomarker analysis|
- Maximum tolerated dose of Lapatinib [ Time Frame: estimated to be 12 months ]Dose Escalation of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544804
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Mark M. Moasser, MD||University of California, San Francisco|