Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353717
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
2006-07-18
Brief Title:
Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Phase II of Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
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:
Basal like breast carcinoma is a Her2 estrogen receptor ER progesterone receptor PR negative breast cancer It is notable for the high level of epidermal growth factor receptor EGFR expression in this tumor subtype
Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux cetuximab with the widely used weekly taxol chemotherapy for the treatment of these women This is a small phase III study
Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux cetuximab with the widely used weekly taxol chemotherapy for the treatment of these women This is a small phase III study
Detailed Description:
Basal like breast carcinoma is a Her2 ER PR negative breast cancer It is notable for the high percentage of EGFR expression in this tumor subtypeWeekly taxol paclitaxel is widely used in breast cancer patients with metastatic disease Erbitux cetuximab is a monoclonal antibody that shown its ability to enhance activity of chemotherapy in colon carcinoma Thus we wanted to combine the use of anti EGFR therapy in the form of Erbitux cetuximab with the widely used weekly taxol chemotherapy for the treatment of women with basal like breast carcinoma This is a small phase II study that will hopefully provide initial data as to the general tolerability and response rate of this combination in this disease Furthermore pathologic analysis will be used to try and assess relation of response with the presence of immunohistochemical markers such as EGFR expression
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