A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00234403|
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : April 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: gefitinib and fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||October 2007|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234403
|Study Director:||AstraZeneca Spain Medical Director, MD||AstraZeneca|