Second Line Breast Cancer Trial

NCT ID: NCT00635713

Last Updated: 2009-04-10

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

588 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-05-31

Study Completion Date

2004-09-30

Brief Summary

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The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Detailed Description

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Conditions

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Advanced Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Faslodex 125mg and Arimidex 1 mg

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

125mg

Anastrozole

Intervention Type DRUG

ARIMIDEX

2

Faslodex 250mg and Arimidex 1mg

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

ARIMIDEX

Fulvestrant

Intervention Type DRUG

250mg

Interventions

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Fulvestrant

125mg

Intervention Type DRUG

Anastrozole

ARIMIDEX

Intervention Type DRUG

Fulvestrant

250mg

Intervention Type DRUG

Other Intervention Names

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Faslodex Faslodex

Eligibility Criteria

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Inclusion Criteria

* postmenopausal women with confirmation of breast cancer
* objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion Criteria

* presence of life-threatening metastatic visceral disease
* previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
* more than 1 prior endocrine medical treatment for advanced breast cancer .
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Guido Hoctin-Boes

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D6995C00021

Identifier Type: -

Identifier Source: secondary_id

9238IL/0021

Identifier Type: -

Identifier Source: org_study_id

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