Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

NCT ID: NCT00255463

Last Updated: 2009-04-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-11-30

Brief Summary

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The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

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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Anastrazole

Intervention Type DRUG

Gefitinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
* Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
* Natural menopause with last menses \> 1 year ago,
* Radiation induced oophorectomy with last menses \> 1 year ago,
* Serum FSH and LH levels clearly in the postmenopausal range for the institution.
* Bilateral oophorectomy

Exclusion Criteria

* Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
* Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Iressa Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Brno, , Czechia

Site Status

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Chomutov, , Czechia

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Ostrava, , Czechia

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Ostrava - Poruba, , Czechia

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Prague, , Czechia

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Clermont-Ferrand, , France

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Montpellier, , France

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Tours, , France

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Villejuif, , France

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Budapest, , Hungary

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Debrecen, , Hungary

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Kecskemét, , Hungary

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Coimbra, , Portugal

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Funchal, , Portugal

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Lisbon, , Portugal

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Santiago de Compostela, A Coruña, Spain

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Jaén, Jaén, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Zaragoza, Zaragoza, Spain

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A Coruña, , Spain

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Gothenburg, , Sweden

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Mölndal, , Sweden

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Stockholm, , Sweden

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Chelmsford, Essex, United Kingdom

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Bournemouth, , United Kingdom

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Croydon, , United Kingdom

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Dundee, , United Kingdom

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Poole, , United Kingdom

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Countries

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Czechia France Hungary Portugal Spain Sweden United Kingdom

Other Identifiers

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D7913C00223

Identifier Type: -

Identifier Source: secondary_id

1839IL/0223

Identifier Type: -

Identifier Source: org_study_id

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