Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

NCT ID: NCT00256698

Last Updated: 2012-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Hormone receptor positive breast cancer first relapse

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

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1 mg oral tablet

2

Anastrozole + Fulvestrant

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

intramuscular injection 250 mg loading dose (LD) regimen

Anastrozole

Intervention Type DRUG

1 mg oral tablet

Interventions

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Fulvestrant

intramuscular injection 250 mg loading dose (LD) regimen

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

* Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis

Exclusion Criteria

* Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
* Premenopausal women
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Henriksson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Brampton, , Canada

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Halifax, , Canada

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Kingston, , Canada

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Ontario, , Canada

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Toronto, , Canada

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San José, , Costa Rica

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Hämeenlinna, , Finland

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Turku, , Finland

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Avignon, , France

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Caen, , France

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Créteil, , France

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Grenoble, , France

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La Chaussée-Saint-Victor, , France

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Perpignan, , France

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Périgueux, , France

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Saint Cyr Sur Louire, , France

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Toulouse, , France

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Augsburg, , Germany

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Cologne, , Germany

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Düsseldorf, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Gifhorn, , Germany

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Großhadern, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Ingolstadt, , Germany

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Kassel, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Magdeburg, , Germany

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Mannheim, , Germany

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Marburg, , Germany

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München, , Germany

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Rostock, , Germany

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Trier, , Germany

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Ulm, , Germany

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Ziwicken, , Germany

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Guatemala City, , Guatemala

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Reykjavik, , Iceland

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Como, , Italy

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Fabriano, , Italy

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Ferrara, , Italy

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Florence, , Italy

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Lugo, , Italy

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Milan, , Italy

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Taormina, , Italy

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Treviglio, , Italy

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Vicenza, , Italy

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Drammen, , Norway

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Ilesund, , Norway

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Oslo, , Norway

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Porsgrunn, , Norway

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Stavanger, , Norway

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Troms, , Norway

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Trondheim, , Norway

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Cascais, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Santa Maria da Feira, , Portugal

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Halmstad, , Sweden

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Helsingborg, , Sweden

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Kalmar, , Sweden

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Karlskrona, , Sweden

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Kristianstad, , Sweden

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Link'ping, , Sweden

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M'lndal, , Sweden

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Malm, , Sweden

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Norrk'ping, , Sweden

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Skellefteå, , Sweden

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Skövde, , Sweden

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Södra Sunderbyn, , Sweden

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Stockholm, , Sweden

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Sundsvall, , Sweden

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Umeå, , Sweden

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V'rnamo, , Sweden

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V'stervik, , Sweden

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Varberg, , Sweden

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Ankara, , Turkey (Türkiye)

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Edirne, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Countries

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Canada Costa Rica Finland France Germany Guatemala Iceland Italy Norway Portugal Sweden Turkey (Türkiye)

Other Identifiers

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9238SW/0001

Identifier Type: -

Identifier Source: secondary_id

FACT

Identifier Type: -

Identifier Source: secondary_id

D6997L00002

Identifier Type: -

Identifier Source: org_study_id