Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098605
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2004-12-07
Brief Title:
Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GW572016 for Brain Metastases in Patients With HER2-Positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth This phase II trial is studying how well lapatinib works in treating brain metastases in patients with stage IV breast cancer and brain metastases
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the objective response rate in the central nervous system CNS complete plus partial responses as assessed by standard MRI to oral GW572016 among patients with progressive brain metastases from HER2-positive breast cancer
SECONDARY OBJECTIVES
I To evaluate the site of first failure CNS extra-CNS both or death and overall survival of patients treated with GW572016 for brain metastases
II To evaluate the overall objective response rate complete plus partial response and time to first progression at any site
III To assess quality of life QOL neurologic QOL and cause of death in patients treated with GW572016 for brain metastases
IV To determine the qualitative and quantitative toxicities associated with oral GW572016 given at a dose of 750 mg orally twice daily
V To evaluate the sensitivity of PET with dedicated brain sequences to detect brain metastases from breast cancer
VI To explore the relationship between decline in PET uptake at 1 week and decline in PET uptake at 8 weeks
VII To characterize the vessel patterns seen on MRI at baseline 8 weeks and 16 weeks of treatment with GW572016
VIII To describe changes in serum HER2 ECD over time IX To describe the baseline EGFR HER2 IGF-IR and degree of HER2 gene amplification in primary tumor blocks
OUTLINE This is an open-label multicenter study
Patients receive oral lapatinib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at 8 weeks
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 05-15 years
I To evaluate the objective response rate in the central nervous system CNS complete plus partial responses as assessed by standard MRI to oral GW572016 among patients with progressive brain metastases from HER2-positive breast cancer
SECONDARY OBJECTIVES
I To evaluate the site of first failure CNS extra-CNS both or death and overall survival of patients treated with GW572016 for brain metastases
II To evaluate the overall objective response rate complete plus partial response and time to first progression at any site
III To assess quality of life QOL neurologic QOL and cause of death in patients treated with GW572016 for brain metastases
IV To determine the qualitative and quantitative toxicities associated with oral GW572016 given at a dose of 750 mg orally twice daily
V To evaluate the sensitivity of PET with dedicated brain sequences to detect brain metastases from breast cancer
VI To explore the relationship between decline in PET uptake at 1 week and decline in PET uptake at 8 weeks
VII To characterize the vessel patterns seen on MRI at baseline 8 weeks and 16 weeks of treatment with GW572016
VIII To describe changes in serum HER2 ECD over time IX To describe the baseline EGFR HER2 IGF-IR and degree of HER2 gene amplification in primary tumor blocks
OUTLINE This is an open-label multicenter study
Patients receive oral lapatinib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at 8 weeks
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 05-15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DFCI 04-199 | None | None | None |