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A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252811
First received: November 1, 2005
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

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:

Drug Information available for: Gefitinib
U.S. FDA Resources

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
  Eligibility

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

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

Locations
Italy
Research Site
Milan, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gefitinib
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013