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
18 Years
N/A
Open (Enrolling)
Both
Immunologic Tests
Both
Immunologic Tests
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 Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Newark, Delaware 19713 |
