Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT00544804
- Phase
- PHASE1
- Status
- Completed
Conditions
- Breast Cancer
- Metastatic Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- lapatinib ditosylate — DRUG
- gene expression analysis — GENETIC
- diagnostic laboratory biomarker analysis — OTHER
Study Details
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.
Key Dates
- Start date
- Aug 31, 2007
- Status verified
- Jul 2014
- Primary completion
- Jun 30, 2013
- Completion
- Dec 31, 2013
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: LapatinibDose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
Primary Outcome Measure
Maximum tolerated dose of Lapatinib [ Time Frame: estimated to be 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | - |
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