A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer|
- To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
- To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
- To estimate the disease control rate at trial closure.
- To estimate overall survival.
- To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
|Study Start Date:||May 2004|
|Study Completion Date:||October 2007|
|Study Director:||AstraZeneca Spain Medical Director, MD||AstraZeneca|