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Brief Title: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
Official Title: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
Study ID: NCT01514565
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Name: Agnieszka Witkiewicz, MD
Affiliation: Thomas Jefferson University
Role: PRINCIPAL_INVESTIGATOR
Name: Gordon Schwartz, MD
Affiliation: Thomas Jefferson University
Role: PRINCIPAL_INVESTIGATOR