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ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

NCT ID: NCT00286117

Last Updated: 2009-05-01

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

PHASE3

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2006-05-31

Brief Summary

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The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

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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

NONE

Study Groups

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1

Anastrozole

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

oral

2

Tamoxifen

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

oral

Interventions

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Anastrozole

oral

Intervention Type DRUG

Tamoxifen

oral

Intervention Type DRUG

Other Intervention Names

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Arimidex ZD1033 Nolvadex

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal status; age ≤75 years;
* histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes;
* oestrogen receptor status positive or unknown;
* primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed

Exclusion Criteria

* Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).
Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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AstraZeneca Arimidex Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Francesco Boccardo, MD

Role: PRINCIPAL_INVESTIGATOR

University and National Cancer Research Institute

Locations

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Research Site

Arezzo, , Italy

Site Status

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Bologna, , Italy

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Casalpusterlengo, , Italy

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Catania, , Italy

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Chieti, , Italy

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Ferrara, , Italy

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Florence, , Italy

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Forlì, , Italy

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Genova, , Italy

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Lugo, , Italy

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Messina, , Italy

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Milan, , Italy

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Monserrato, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Pinerolo, , Italy

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Roma, , Italy

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Rovigo, , Italy

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Sanremo, , Italy

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Saronno, , Italy

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Sassari, , Italy

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Terni, , Italy

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Torino, , Italy

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Trieste, , Italy

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Research Site

Vicenza, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ITA

Identifier Type: -

Identifier Source: secondary_id

1033IT/0002

Identifier Type: -

Identifier Source: org_study_id

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