A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

Phase 2

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT00252811
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇮🇹 Milan, Italy