This is a prospective observational study aimed to validate biomarkers that predict response.
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.
Study Type
OBSERVATIONAL
Enrollment
70
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGHistological 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.
Time frame: Nine weeks
Correlation of RB and other biomarkers
1. Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR 2. Correlation between RB-status, RB and PTEN status and other biomarkers with recurrence free survival (RFS) and overall survival (OS)
Time frame: Nine weeks
Determine the utility of an RB molecular test
Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.
Time frame: Assessed within 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.