Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

This study has been terminated.
(Study termination due to negative Phase III of another study product from same technology platform.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476111
First received: November 10, 2011
Last updated: March 6, 2015
Last verified: February 2015
  Purpose
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.

Condition
Neoplasms, Breast

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Disease free interval [ Time Frame: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Tissue

Enrollment: 117
Study Start Date: December 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Patients with primary invasive breast cancer

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476111

Locations
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
GSK Investigational Site
Plantation, Florida, United States, 33324
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29414
United States, Texas
GSK Investigational Site
Amarillo, Texas, United States, 79106
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Namur, Belgium, 5000
Germany
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
GSK Investigational Site
Homburg, Saarland, Germany, 66421
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09116
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
GSK Investigational Site
Roma, Lazio, Italy, 00189
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Torino, Piemonte, Italy, 10126
Russian Federation
GSK Investigational Site
Ryazan, Russian Federation, 390011
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
United Kingdom
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476111     History of Changes
Other Study ID Numbers: 115400 
Study First Received: November 10, 2011
Last Updated: March 6, 2015
Health Authority: Germany: Paul-Ehrlich-Institut
France: Agence Française de Sécurité Sanitaire des Produit de Santé
Italy: Istituto Europeo di Oncologia
Germany: Bundesamt für Sera und Impfstoffe
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
tumor antigens
observational
breast cancer
biomarkers
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2016