Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

NCT ID: NCT00287534

Last Updated: 2009-06-09

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

1059 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

2004-09-30

Brief Summary

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The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer

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

* Signed informed consent,
* Post-menopausal women ≤75 years,
* histologically confirmed invasive breast carcinoma (no distant metastases),
* positive hormone receptor status,
* continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery

Exclusion Criteria

* menopause status maintained by medication,
* pre-operative chemotherapy or hormone therapy or radiation therapy,
* relapse or second carcinoma or previous cancerous disease,
* breast carcinoma in situ,
* simultaneous carcinoma of the opposite side or secondary breast,
* 10 or more tumour-infiltrated lymph nodes.
* serious accompanying diseases
Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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German Adjuvant Breast Cancer Group

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Manfred Kaufmann, MD

Role: PRINCIPAL_INVESTIGATOR

German Adjuvant Breast Cancer Group

Locations

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Albstadt, , Germany

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Berlin, , Germany

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Cloppenburg, , Germany

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Eggenfelden, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanau, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Hoyerswerda, , Germany

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Idar-Oberstein, , Germany

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Jena, , Germany

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Karlsruhe, , Germany

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Kassel, , Germany

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Kiel, , Germany

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Leonberg, , Germany

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Lingen, , Germany

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Lübeck, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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München, , Germany

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Münster, , Germany

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Neustadt, , Germany

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Osnabrück, , Germany

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Paderborn, , Germany

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Pforzheim, , Germany

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Recklinghausen, , Germany

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Rosenheim, , Germany

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Rostock, , Germany

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Rüsselsheim am Main, , Germany

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Schleswig, , Germany

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Siegen, , Germany

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Titisee-Neustadt, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Waiblingen, , Germany

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Westerstede, , Germany

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Worms, , Germany

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Würzburg, , Germany

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Countries

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Germany

Other Identifiers

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ARNO-95

Identifier Type: -

Identifier Source: secondary_id

1033GR/0001

Identifier Type: -

Identifier Source: org_study_id

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