A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252811

Enrollment

Registered

2005-11-15

Start date

2004-02-29

Completion date

Unknown

Last updated

2011-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGGefitinib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds.	—
To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue.	—
To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies	—
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.	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026