Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to identify and prioritize the mutated targets. Therapeutic options, based on the genetic profile of each patient's tumor, will be discussed and an appropriate molecularly-selected agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as treatment for the patient. This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who are scheduled for medically indicated surgical biopsy or resection will be enrolled and therapeutic options, based on the genetic profile of each patient's tumor, will be discussed with the patient. Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy. A 30% increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate prior therapy will be considered as evidence of clinical benefit from the selected therapy. The secondary endpoints are best response to the molecularly-selected therapy, overall survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC. The study is designed to demonstrate that the collection and analysis of these tumor samples is feasible.
Study Type
OBSERVATIONAL
Enrollment
14
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Virginia Oncology Assocites
Elizabeth City, North Carolina, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology-Memorial City
Houston, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
...and 8 more locations
Time-to-progression (TTP)
Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy.
Time frame: Throughout study, for up to 3 years
Best response
Best response to therapy selected based on genomic analysis will be determined. Response will be evaluated in this study using the international criteria published by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1.
Time frame: To molecularly selected therapy, for up to 3 years
Overall survival
Survival will be measured, from the selected treatment start date to the date of death or the last date the patient was known to be alive.
Time frame: Throughout the study, for up to 3 years
Genetic mutation evaluation
Genomic analysis of whole blood and resected tumor will be done
Time frame: After surgical resection
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