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Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

NCT ID: NCT00357110

Last Updated: 2010-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-10-31

Brief Summary

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Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast neoplasms breast cancer early breast cancer oncology cancer breast cancer micrometastasis fulvestrant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Anastrozole monotherapy

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1 mg oral tablet

2

Anastrozole + Fulvestrant

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

intramuscular injection

Anastrozole

Intervention Type DRUG

1 mg oral tablet

Interventions

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Fulvestrant

intramuscular injection

Intervention Type DRUG

Anastrozole

1 mg oral tablet

Intervention Type DRUG

Other Intervention Names

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Faslodex ZD9238 Arimidex ZD1033

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation

Exclusion Criteria

* Inflammatory and/or metastatic breast cancer.
* Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
* History of bleeding diathesis.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Breast Cancer Established Brands Team Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Feldkirch, , Austria

Site Status

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Graz, , Austria

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Innsbruck, , Austria

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Klagenfurt, , Austria

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Leoben, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Sankt Veit im Pongau, , Austria

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Vienna, , Austria

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Wiener Neustadt, , Austria

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Bayreuth, , Germany

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Essen, , Germany

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Hamburg-Eppendorf, , Germany

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Heidelberg, , Germany

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Munich, , Germany

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Rostock, , Germany

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Tübingen, , Germany

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Drammen, , Norway

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Fredrikstad, , Norway

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Kristiansand, , Norway

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Oslo, , Norway

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Porsgrunn, , Norway

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Stavanger, , Norway

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Trondheim, , Norway

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Tønsberg, , Norway

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Countries

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Austria Germany Norway

Other Identifiers

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ABCSG21

Identifier Type: -

Identifier Source: secondary_id

Eudract No 2005-005715-22

Identifier Type: -

Identifier Source: secondary_id

D6990C00001

Identifier Type: -

Identifier Source: org_study_id