Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

Neoplasms, Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01476111
• Other study ID #: 115400
• Status: Terminated
• Phase: N/A
• First received: November 10, 2011
• Last updated: March 6, 2015
• Start date: December 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutFrance: Agence Française de Sécurité Sanitaire des Produit de SantéItaly: Istituto Europeo di OncologiaGermany: Bundesamt für Sera und ImpfstoffeBelgium: Federal Agency for Medicines and Health Products, FAMHPUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Namur
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Erlangen	Bayern
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Homburg	Saarland
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Italy	GSK Investigational Site	Aviano (PN)	Friuli-Venezia-Giulia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Torino	Piemonte
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
United Kingdom	GSK Investigational Site	Bournemouth
United Kingdom	GSK Investigational Site	Derby
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	Nottingham
United Kingdom	GSK Investigational Site	Poole
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Newark	Delaware
United States	GSK Investigational Site	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of a specific predictive gene expression signature in tumor tissues		At randomization and at definitive surgery which may be up to 30 weeks post randomization.	No
Primary	The presence of immune infiltration in tumor tissues		At randomization and at definitive surgery which may be up to 30 weeks post randomization.	No
Primary	The presence of other candidate biomarkers in tumor tissues		At randomization and at definitive surgery which may be up to 30 weeks post randomization.	No
Primary	The pathological response (complete response or partial response) in the breast.		At definitive surgery which may be up to 30 weeks post randomization.	No
Primary	Disease free interval		Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.	No
Primary	Disease free survival		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.	No
Primary	Overall survival		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.	No