A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252811

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: ZD1839 Progesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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

Study ID Numbers:	D7913C00509, 1839IL/0509
Study First Received:	November 1, 2005
Last Updated:	January 8, 2007
ClinicalTrials.gov Identifier:	NCT00252811
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study placed in the following topic categories:

Progesterone
Skin Diseases
Breast Neoplasms
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009