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Docetaxel given as 75 mg/m2 IV every 3 weeks combined with ZD1839 (IRESSA) 250 mg orally daily until disease progression or withdrawal criteria are met.

ZD1839 in combination with docetaxel

Norman Wolmark, MD

The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839.

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 and/or 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 mechanism(s) of anti-tumor activity of docetaxel remain unclear and combinations of signal transduction pathway inhibition and/or 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.

Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer

A Phase 2, Multi-Center Trial of ZD1839 (IRESSA) in Combination With Docetaxel as First-Line Treatment in Patients With Advanced Breast Cancer

AstraZeneca

NSABP Foundation Inc

Norman Wolmark, MD/Chairman, NSABP Foundation Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer	NCT00052169	Breast Neoplasm...	ZD1839 in combi...	18 Years -	NSABP Foundation Inc
Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer	NCT00052169	Breast Neoplasm...	ZD1839 in combi...	18 Years -	NSABP Foundation Inc
Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer	NCT00052169	Breast Neoplasm...	ZD1839 in combi...	18 Years -	NSABP Foundation Inc

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