Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019812
Status:
COMPLETED
Last Update Posted:
2012-03-23
First Post:
2001-07-11
Brief Title:
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Trastuzumab Herceptin and Paclitaxel in Patients With HER2-Overexpressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2003-04
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2
PURPOSE Phase II trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses HER2
Detailed Description:
OBJECTIVES
Determine the pharmacokinetics and pharmacodynamics of trastuzumab Herceptin and paclitaxel in patients with HER2-overexpressing metastatic breast cancer
Provide access to trastuzumab and paclitaxel for these patients
OUTLINE Patients receive trastuzumab Herceptin IV over 30-90 minutes and paclitaxel IV over 1 hour weekly Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 2 years
Determine the pharmacokinetics and pharmacodynamics of trastuzumab Herceptin and paclitaxel in patients with HER2-overexpressing metastatic breast cancer
Provide access to trastuzumab and paclitaxel for these patients
OUTLINE Patients receive trastuzumab Herceptin IV over 30-90 minutes and paclitaxel IV over 1 hour weekly Patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses Courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 2 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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067227 | None | None | None |
| 99-C-0121 | None | None | None |
| NCI-T98-0087 | None | None | None |