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A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

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ClinicalTrials.gov Identifier: NCT00252811
Recruitment Status : Withdrawn
First Posted : November 15, 2005
Last Update Posted : January 28, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gefitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Primary Outcome Measures :
  1. 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
  2. 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 :
  1. To assess the effect of 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds.
  2. 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.
  3. To determine the effect of ZD1839 on HER-2 phosphorylation and other biomarkers in the surgical (endpoint) specimens when compared with the baseline biopsies
  4. To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies
  5. To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00252811     History of Changes
Other Study ID Numbers: 1839IL/0509
D7913C00509 ( Other Identifier: AZ IMPACT )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action