Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
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.
Observational Model: Cohort, Time Perspective: Prospective
Histological status of retinoblastoma tumour suppressor (RB)
The primary endpoint is to assess the impact of histological RB-status on pathological complete response (pCR). pCR is a well validated surrogate of chemotherapy sensitivity and allows the identification of a group of patients with excellent prognosis.
Agnieszka Witkiewicz, MD
Thomas Jefferson University
United States: Institutional Review Board
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