A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

This study has been withdrawn prior to enrollment.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 1, 2005
Last updated: January 27, 2011
Last verified: January 2011
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.

Condition Intervention Phase
Breast Cancer
Drug: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment: 60
Study Start Date: February 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00252811

Research Site
Milan, Italy
Sponsors and Collaborators
Study Director: AstraZeneca Italy Medical Director, MD AstraZeneca
Principal Investigator: A Decensi, MD Istituto Europeo di Oncologia di Milano
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252811     History of Changes
Other Study ID Numbers: 1839IL/0509  D7913C00509 
Study First Received: November 1, 2005
Last Updated: January 27, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on February 11, 2016