Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 4:04 PM
Study NCT ID:
NCT00006104
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2000-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VCC-BRE-9823 | None | None | View | |
| NCI-G00-1830 | None | None | View |