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Study termination due to negative Phase III of another study product from same technology platform.
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This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients with primary invasive breast cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| The presence of immune infiltration in tumor tissues | At randomization and at definitive surgery which may be up to 30 weeks post randomization. | |
| The presence of other candidate biomarkers in tumor tissues | 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. | At definitive surgery which may be up to 30 weeks post randomization. | |
| Disease free interval | Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years. | |
| 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. | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Not applicable.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Newark | Delaware | 19713 | United States | ||
| GSK Investigational Site |
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Tissue
| Plantation |
| Florida |
| 33324 |
| United States |
| GSK Investigational Site | Charleston | South Carolina | 29414 | United States |
| GSK Investigational Site | Amarillo | Texas | 79106 | United States |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Namur | 5000 | Belgium |
| GSK Investigational Site | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| GSK Investigational Site | Erlangen | Bavaria | 91054 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44137 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45136 | Germany |
| GSK Investigational Site | Homburg | Saarland | 66421 | Germany |
| GSK Investigational Site | Chemnitz | Saxony | 09116 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| GSK Investigational Site | Naples | Campania | 80131 | Italy |
| GSK Investigational Site | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| GSK Investigational Site | Rome | Lazio | 00189 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20141 | Italy |
| GSK Investigational Site | Pavia | Lombardy | 27100 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10126 | Italy |
| GSK Investigational Site | Ryazan | 390011 | Russia |
| GSK Investigational Site | Saint Petersburg | 197022 | Russia |
| GSK Investigational Site | Saint Petersburg | 197758 | Russia |
| GSK Investigational Site | Bournemouth | BH7 7DW | United Kingdom |
| GSK Investigational Site | Derby | DE22 3DT | United Kingdom |
| GSK Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| GSK Investigational Site | Nottingham | NG5 1PB | United Kingdom |
| GSK Investigational Site | Poole | BH15 2JB | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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