Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096434
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2004-11-09
Brief Title:
Sorafenib in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Oral Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline andor Taxane
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- andor taxane-containing regimen receiving sorafenib
II Assess the toxicity profile of this drug in these patients III Determine time to disease progression and survival time of patients treated with this drug
IV Correlate pre-treatment levels of activated ERK12 with tumor response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months until disease progression and then every 3 months for up to 5 years
I Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- andor taxane-containing regimen receiving sorafenib
II Assess the toxicity profile of this drug in these patients III Determine time to disease progression and survival time of patients treated with this drug
IV Correlate pre-treatment levels of activated ERK12 with tumor response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months until disease progression and then every 3 months for up to 5 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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01817 | REGISTRY | None | None |
| CDR0000393224 | None | None | None |
| NCCTG-N0336 | None | None | None |
| N0336 | OTHER | None | None |
| N0336 | OTHER | None | None |