An observational study in Neoplasms, Breast, sponsored by GlaxoSmithKline. Terminated at 29 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-09.
Sponsored by GlaxoSmithKline · Observational
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 117 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Not applicable.
Patients with primary invasive breast cancer
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.
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.
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.
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.
Disease free interval
Time frame: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
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.
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.
This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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