Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
This is a prospective observational study aimed to validate biomarkers that predict response.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.|
- Histological status of retinoblastoma tumour suppressor (RB) [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]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.
- Correlation of RB and other biomarkers [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]
- Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR
- Correlation between RB-status, RB and PTEN status and other biomarkers with recurrence free survival (RFS) and overall survival (OS)
- Determine the utility of an RB molecular test [ Time Frame: Assessed within 1 year ] [ Designated as safety issue: No ]Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
|Contact: Agnieszka Witkiewicz, MD||215-955-3778||Agnieszka.Witkiewicz@jefferson.edu|
|Contact: Gordon Schwartz, MD||215-955-6999||Gordon.Schwartz@jefferson.edu|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Agnieszka Witkiewicz, MD 215-955-3778 Agnieszka.Witkiewicz@jefferson.edu|
|Contact: Gordon Schwartz, MD 215-955-6999 Gordon.Schwartz@jefferson.edu|
|Sub-Investigator: Matias Valsecchi, MD|
|Sub-Investigator: A. Kathleen McClendon, PhD|
|Sub-Investigator: Adam Berger, MD|
|Sub-Investigator: Sunny Lee, MD|
|Sub-Investigator: Barbara Cavanaugh, MD|
|Sub-Investigator: Frederick Fellin, MD|
|Sub-Investigator: Allison Zibelli, MD|
|Sub-Investigator: Tiffany Avery, MD|
|Sub-Investigator: Rebecca Jaslow, MD|
|Sub-Investigator: Erik Knudsen, PhD|
|Principal Investigator:||Agnieszka Witkiewicz, MD||Thomas Jefferson University|
|Principal Investigator:||Gordon Schwartz, MD||Thomas Jefferson University|