Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004013
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Paclitaxel With or Without Trastuzumab Following Peripheral Stem Cell Transplantation in Treating Patients With Refractory Stage IV Breast Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Treatment of Refractory Stage IV Metastatic Breast Cancer With Weekly Paclitaxel or Weekly Paclitaxel and Herceptin Following AutologousSyngeneic Stem Cell Transplant
Status:
COMPLETED
Status Verified Date:
2010-03
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 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 Paclitaxel may stop the growth of breast cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to compare the effectiveness of paclitaxel with or without trastuzumab following peripheral stem cell transplantation in treating patients who have refractory stage IV breast cancer
PURPOSE Phase II trial to compare the effectiveness of paclitaxel with or without trastuzumab following peripheral stem cell transplantation in treating patients who have refractory stage IV breast cancer
Detailed Description:
OBJECTIVES I Determine the toxicity of paclitaxel with or without trastuzumab following high dose chemotherapy with autologous or syngeneic peripheral blood stem cell transplantation in patients with stage IV breast cancer II Assess the overall survival of these patients
OUTLINE Patients begin study treatment within 50-150 days after autologous or syngeneic peripheral blood stem cell transplantation Patients are stratified according to overexpression of HER2-Neu yes vs no which determines the type of therapy Arm I overexpression of HER2-Neu Patients receive paclitaxel IV over 60 minutes followed by the initial loading dose of trastuzumab IV over 90 minutes If the loading dose is tolerated well then patients receive maintenance trastuzumab IV over 30 minutes Treatment with paclitaxel followed by maintenance trastuzumab repeats once every week for 12 weeks in the absence of disease progression or unacceptable toxicity Arm II no overexpression of Her2-Neu Patients receive paclitaxel IV over 60 minutes once every week for 12 weeks Patients with hormone receptor positive disease also receive antihormonal therapy tamoxifen or anastrozole as clinically indicated Patients with isolated metastasis such as a single bone lesion may receive radiotherapy to that site after completion of study treatment Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study over 2-3 years
OUTLINE Patients begin study treatment within 50-150 days after autologous or syngeneic peripheral blood stem cell transplantation Patients are stratified according to overexpression of HER2-Neu yes vs no which determines the type of therapy Arm I overexpression of HER2-Neu Patients receive paclitaxel IV over 60 minutes followed by the initial loading dose of trastuzumab IV over 90 minutes If the loading dose is tolerated well then patients receive maintenance trastuzumab IV over 30 minutes Treatment with paclitaxel followed by maintenance trastuzumab repeats once every week for 12 weeks in the absence of disease progression or unacceptable toxicity Arm II no overexpression of Her2-Neu Patients receive paclitaxel IV over 60 minutes once every week for 12 weeks Patients with hormone receptor positive disease also receive antihormonal therapy tamoxifen or anastrozole as clinically indicated Patients with isolated metastasis such as a single bone lesion may receive radiotherapy to that site after completion of study treatment Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study over 2-3 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 |
|---|---|---|---|
| CDR0000067230 | REGISTRY | PDQ | None |
| FHCRC-133800 | None | None | None |
| GENENTECH-FHCRC-133800 | None | None | None |
| NCI-G99-1557 | None | None | None |