Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

Terminated

• Conditions: Neoplasms, Breast

• Registration Number: NCT01476111
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Study Start: 2011-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 other candidate biomarkers in tumor tissues	At randomization and 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.
The presence of immune infiltration 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 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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Poole, United Kingdom