A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00252811|
Recruitment Status : Withdrawn
First Posted : November 15, 2005
Last Update Posted : January 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Gefitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery|
|Study Start Date :||February 2004|
- Estimate the effect of ZD1839 compared with placebo on the change in tumour cell proliferation in patients who have completely ER negative & PgR negative breast cancer
- Aassessment of biomarker Ki-67 in breast cancer tissue at baseline by core biopsy and after 4 weeks on the surgical specimen
- To assess the effect of 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds.
- To correlate the expression of tissue biomarkers (HER family and epidermal growth factor [EGF] related pathways) in the baseline biopsy sample and in the surgical (endpoint) specimen with the anti-proliferative effect of ZD1839.
- To determine the effect of ZD1839 on HER-2 phosphorylation and other biomarkers in the surgical (endpoint) specimens when compared with the baseline biopsies
- To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies
- To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue.
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): NCT00252811
|Study Director:||AstraZeneca Italy Medical Director, MD||AstraZeneca|
|Principal Investigator:||A Decensi, MD||Istituto Europeo di Oncologia di Milano|