Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT00544804
Status:
COMPLETED
Last Update Posted:
2014-07-02
First Post:
2007-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2
Sponsor:
University of California, San Francisco
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Primary
* 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.
Secondary
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: