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A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

NCT ID: NCT00252811

Last Updated: 2011-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gefitinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Italy Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

A Decensi, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Europeo di Oncologia di Milano

Locations

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Research Site

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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D7913C00509

Identifier Type: OTHER

Identifier Source: secondary_id

1839IL/0509

Identifier Type: -

Identifier Source: org_study_id

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