Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

NCT ID: NCT01476111

Last Updated: 2015-03-09

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

TERMINATED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-07-31

Brief Summary

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This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.

Detailed Description

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Conditions

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Neoplasms, Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients with primary invasive breast cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The patient has 18 years of age or older at the time of consent.
* The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study.
* The patient has a histologically or cytologically confirmed primary invasive breast cancer.
* The patient has provided written informed consent before any new information or new material is provided to the Sponsor.
* The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
* The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.

Exclusion Criteria

Not applicable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Newark, Delaware, United States

Site Status

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Plantation, Florida, United States

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Charleston, South Carolina, United States

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Amarillo, Texas, United States

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Brussels, , Belgium

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Namur, , Belgium

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Tübingen, Baden-Wurttemberg, Germany

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Erlangen, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Rostock, Mecklenburg-Vorpommern, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Homburg, Saarland, Germany

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Chemnitz, Saxony, Germany

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Kiel, Schleswig-Holstein, Germany

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Napoli, Campania, Italy

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Aviano (PN), Friuli Venezia Giulia, Italy

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Rome, Lazio, Italy

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Milan, Lombardy, Italy

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Pavia, Lombardy, Italy

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Turin, Piedmont, Italy

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Bournemouth, , United Kingdom

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Derby, , United Kingdom

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Edinburgh, , United Kingdom

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Nottingham, , United Kingdom

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Poole, , United Kingdom

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Countries

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United States Belgium Germany Italy Russia United Kingdom

Other Identifiers

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115400

Identifier Type: -

Identifier Source: org_study_id

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