NCT01514565

Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer

Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective observational study aimed to validate biomarkers that predict response.

Detailed description

This is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. Patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. Patients will receive standard of care, FDA-approved and clinically validated chemotherapy regimens. The biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. Data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. The primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment.

Conditions

• Breast Cancer

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2012-01-23
• Last updated: 2015-03-18

Locations

1 site across 1 country: United States