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

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: Lapatinib
    Dose 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)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-

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