Clinical trial NCT01476111: Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer
Official title: A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neoplasms, Breast
Keywords: tumor antigens
observational
breast cancer
biomarkers
Neoadjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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:

Not applicable.

Primary outcomes:
measure: The presence of a specific predictive gene expression signature in tumor tissues
timeFrame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
measure: The presence of immune infiltration in tumor tissues
timeFrame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
measure: The presence of other candidate biomarkers in tumor tissues
timeFrame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
measure: The pathological response (complete response or partial response) in the breast.
timeFrame: At definitive surgery which may be up to 30 weeks post randomization.
measure: Disease free interval
timeFrame: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
measure: Disease free survival
timeFrame: 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.
measure: Overall survival
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: GSK Investigational Site
state: Delaware
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Namur
country: Belgium
facility: GSK Investigational Site
city: Tuebingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Aviano (PN)
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pavia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: Derby
country: United Kingdom
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
city: Poole
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: