NCT00252811

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

First QC Date

November 1, 2005

Last Update Submit

January 27, 2011

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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.

Interventions

GefitinibDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-confirmed ER- and PgR- primary breast cancer
  • Stage T .5 cm, N0-1, M0
  • No previous treatment for breast cancer

You may not qualify if:

  • ALT or AST greater than 2.5 times the ULRR
  • Metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Italy Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

  • A Decensi, MD

    Istituto Europeo di Oncologia di Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 15, 2005

Study Start

February 1, 2004

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

IT(1)