Back to resultsA Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Histologically-confirmed ER- and PgR- primary breast cancer Stage T .5 cm, N0-1, M0 No previous treatment for breast cancer Exclusion Criteria: ALT or AST greater than 2.5 times the ULRR Metastatic disease
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252811
Brief Title
A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Primary Outcome Measure Information:
Title
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
Title
Aassessment of biomarker Ki-67 in breast cancer tissue at baseline by core biopsy and after 4 weeks on the surgical specimen
Secondary Outcome Measure Information:
Title
To assess the effect of 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds.
Title
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.
Title
To determine the effect of ZD1839 on HER-2 phosphorylation and other biomarkers in the surgical (endpoint) specimens when compared with the baseline biopsies
Title
To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies
Title
To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically-confirmed ER- and PgR- primary breast cancer
Stage T .5 cm, N0-1, M0
No previous treatment for breast cancer
Exclusion Criteria:
ALT or AST greater than 2.5 times the ULRR
Metastatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Italy Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
A Decensi, MD
Organizational Affiliation
Istituto Europeo di Oncologia di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
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