Evaluation of specific biomarkers in primary invasive breast cancer
Trial overview
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.
The presence of immune infiltration in tumor tissues
Timeframe: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
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.
The pathological response (complete response or partial response) in the breast.
Timeframe: At definitive surgery which may be up to 30 weeks post randomization.
Disease free interval
Timeframe: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
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.
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.
Participation 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.
- Not applicable.
- 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.
The patient has 18 years of age or older at the time of consent.
- Not applicable.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.