Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004925
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-03-07
Brief Title:
Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced Inflammatory or Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Study of TLC D-99 Plus Herceptin as First or Second Line Therapy for Patients With Locally Advanced Inflammatory or Metastatic 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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase III trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have locally advanced inflammatory or metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have locally advanced inflammatory or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the safety especially the cardiac safety of doxorubicin HCl liposome and trastuzumab Herceptin as first- or second-line therapy in women with metastatic inflammatory or locally advanced breast cancer
OUTLINE Patients are stratified according to prior anthracycline therapy yes vs no
Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression
Patients are followed for at least 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the safety especially the cardiac safety of doxorubicin HCl liposome and trastuzumab Herceptin as first- or second-line therapy in women with metastatic inflammatory or locally advanced breast cancer
OUTLINE Patients are stratified according to prior anthracycline therapy yes vs no
Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression
Patients are followed for at least 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1684 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067609 | REGISTRY | None | None |
| LIPO-D9905 | None | None | None |