A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234403
|Study Director:||AstraZeneca Spain Medical Director, MD||AstraZeneca|