SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer

NCT ID: NCT00272740

Last Updated: 2007-02-09

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

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Brief Summary

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The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fulvestrant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological/cytological confirmation of breast cancer
* progression under treatment with an aromatase inhibitor
* At least one measurable or non-measurable lesion

Exclusion Criteria

* Prior treatment for breast cancer with more than 2 different hormonal agents
* More than 1 chemotherapy for advanced disease
* Presence of life-threatening metastatic visceral disease
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Switzerland Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Leuven, , Belgium

Site Status

Research Site

Aarau, , Switzerland

Site Status

Research Site

Bern, , Switzerland

Site Status

Research Site

Geneva, , Switzerland

Site Status

Research Site

Lausanne, , Switzerland

Site Status

Research Site

Mendrisio, , Switzerland

Site Status

Research Site

Milano, , Switzerland

Site Status

Research Site

Sankt Gallen, , Switzerland

Site Status

Countries

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Belgium Switzerland

Other Identifiers

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SAKK

Identifier Type: -

Identifier Source: secondary_id

21/00

Identifier Type: -

Identifier Source: secondary_id

9238SZ/0001

Identifier Type: -

Identifier Source: org_study_id

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