Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

March 6, 2015 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Namur, Belgium, 5000
        • GSK Investigational Site
  • Germany
    • Baden-Wuerttemberg
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076
        • GSK Investigational Site
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • GSK Investigational Site
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09116
        • GSK Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • GSK Investigational Site
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Friuli-Venezia-Giulia
      • Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00189
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • GSK Investigational Site
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • GSK Investigational Site
  • Russian Federation
      • Ryazan, Russian Federation, 390011
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 197758
        • GSK Investigational Site
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • GSK Investigational Site
      • Derby, United Kingdom, DE22 3DT
        • GSK Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • GSK Investigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • GSK Investigational Site
      • Poole, United Kingdom, BH15 2JB
        • GSK Investigational Site
  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
    • Florida
      • Plantation, Florida, United States, 33324
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • GSK Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who provided a pretreatment tumor sample for Wilms' Tumor 1 (WT1) expression screening in the context of a neoadjuvant interventional study (111172 (WT1-AS15-BRS-001 (NEOADJ)), but who were not included into the active phase of this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients with primary invasive breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The presence of a specific predictive gene expression signature in tumor tissues
Time Frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of immune infiltration in tumor tissues
Time Frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of other candidate biomarkers in tumor tissues
Time Frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The pathological response (complete response or partial response) in the breast.
Time Frame: At definitive surgery which may be up to 30 weeks post randomization.
At definitive surgery which may be up to 30 weeks post randomization.
Disease free interval
Time Frame: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
Disease free survival
Time Frame: Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.
Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.
Overall survival
Time Frame: Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.
Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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