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A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Immunologic Tests

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Trial Information

A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The presence of a specific predictive gene expression signature in tumor tissues

Outcome Time Frame:

At randomization and at definitive surgery which may be up to 30 weeks post randomization.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

France: AFSSAPS: Agence Française de Sécurité Sanitaire des Produits de Santé

Study ID:

115400

NCT ID:

NCT01476111

Start Date:

November 2011

Completion Date:

July 2023

Related Keywords:

  • Immunologic Tests
  • tumor antigens
  • observational
  • biomarkers
  • Neoadjuvant
  • breast cancer
  • Breast Neoplasms

Name

Location

GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteNewark, Delaware  19713