Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006825
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2000-12-06
Brief Title:
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer
PURPOSE Phase III trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer
Detailed Description:
OBJECTIVES
Determine the toxicity including cardiac toxicity of doxorubicin HCl liposome and trastuzumab Herceptin in women with advanced HER-2neu-overexpressing breast cancer
Determine the efficacy of this regimen in these patients
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 followed by trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the toxicity including cardiac toxicity of doxorubicin HCl liposome and trastuzumab Herceptin in women with advanced HER-2neu-overexpressing breast cancer
Determine the efficacy of this regimen in these patients
OUTLINE Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 followed by trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1878 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-0012 | None | None | None |
| ALZA-00-001-ii | None | None | None |