Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00098605
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2004-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases
Sponsor:
National Cancer Institute (NCI)
Organization:
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 0.5-1.5 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 0.5-1.5 years.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DFCI 04-199 | None | None | View |