Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006104
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2000-08-03
Brief Title:
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2Neu Overexpressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate of women with HER2-neu overexpressing recurrent or metastatic breast cancer treated with trastuzumab Herceptin in combination with docetaxel II Determine the toxicity of this treatment regimen in these patients III Determine the duration of response to this treatment regimen in these patients IV Determine the time to progression in these patients after receiving this treatment regimen V Compare HER2-neu overexpression as determined by fluorescent in situ hybridization FISH versus immunohistochemistry and correlate these findings with response to this treatment regimen in these patients VI Correlate HER2-neu activation by immunohistochemistry and the extracellular domain of HER2-neu by ELISA with response to this treatment regimen in these patients
OUTLINE This is a multicenter study Patients receive docetaxel IV over 30 minutes weekly for 6 weeks plus trastuzumab Herceptin IV over 30-90 minutes weekly for 8 weeks Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity Patients are followed monthly for 3 months every 3 months for 9 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 18-34 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive docetaxel IV over 30 minutes weekly for 6 weeks plus trastuzumab Herceptin IV over 30-90 minutes weekly for 8 weeks Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity Patients are followed monthly for 3 months every 3 months for 9 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 18-34 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-G00-1830 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |
| VU-VCC-BRE-9823 | None | None | None |