Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052169
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2003-01-24
Brief Title:
Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase 2 Multi-Center Trial of ZD1839 IRESSA in Combination With Docetaxel as First-Line Treatment in Patients With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839
Detailed Description:
Patients with advanced breast cancer continue to have an extremely poor prognosis with an average life expectancy of approximately 2 years Novel treatments designed to exploit biologic properties of the tumor are urgently required as a means to improve the outcome for the large numbers of patients who relapse after receiving optimal chemotherapy treatments
Overexpresssion of EGFR andor TGF-alpha is frequent in human breast cancer and has been correlated in many cases with poor prognostic features Inhibition of the EGFR pathway has been proposed as a potential therapeutic modality in advanced breast cancer The antiproliferative activity of ZD 1839 in combination with cytotoxic drugs such as docetaxel was evaluated in breast cancer cell lines ZR-75-1 and MCF-10A ras that coexpress EGFR and TGF-alpha Combination treatment demonstrated dose dependent supra-additive growth inhibition and markedly enhanced apoptotic cell death
Although taxanes bind to the microtubular network in cells that is essential for mitotic and interphase cellular functions the mechanism by which these agents induce cell death is not entirely clear Docetaxel has also shown dose-dependent anti-angiogenic activity Thus the mechanisms of anti-tumor activity of docetaxel remain unclear and combinations of signal transduction pathway inhibition andor anti-angiogenesis may provide potentiation of concurrent ZD 1839 and docetaxel therapy
This phase 2 trial is designed to prospectively investigate the efficacy and safetey of combination therapy with ZD 1839 and docetaxel in patients with metastatic breast cancer
Overexpresssion of EGFR andor TGF-alpha is frequent in human breast cancer and has been correlated in many cases with poor prognostic features Inhibition of the EGFR pathway has been proposed as a potential therapeutic modality in advanced breast cancer The antiproliferative activity of ZD 1839 in combination with cytotoxic drugs such as docetaxel was evaluated in breast cancer cell lines ZR-75-1 and MCF-10A ras that coexpress EGFR and TGF-alpha Combination treatment demonstrated dose dependent supra-additive growth inhibition and markedly enhanced apoptotic cell death
Although taxanes bind to the microtubular network in cells that is essential for mitotic and interphase cellular functions the mechanism by which these agents induce cell death is not entirely clear Docetaxel has also shown dose-dependent anti-angiogenic activity Thus the mechanisms of anti-tumor activity of docetaxel remain unclear and combinations of signal transduction pathway inhibition andor anti-angiogenesis may provide potentiation of concurrent ZD 1839 and docetaxel therapy
This phase 2 trial is designed to prospectively investigate the efficacy and safetey of combination therapy with ZD 1839 and docetaxel in patients with metastatic breast cancer
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