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Brief Title: Triple Negative Breast Cancer Biomarker Study
Official Title: Triple Negative Breast Cancer Biomarker Study
Study ID: NCT01111175
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Virginia Oncology Associates, Chesapeake, Virginia, United States
Virginia Oncology Associates, Hampton, Virginia, United States
Virginia Oncology Associates, Newport News, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Virginia Oncology Associates, Virginia Beach, Virginia, United States
Virginia Oncology Associates, Williamsburg, Virginia, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Name: Joyce A O'Shaughnessy, MD
Affiliation: US Oncology Research
Role: PRINCIPAL_INVESTIGATOR
Name: Daniel Von Hoff, MD
Affiliation: Translational Drug Development
Role: PRINCIPAL_INVESTIGATOR
Name: John Carpten, PhD
Affiliation: Translational Drug Development
Role: PRINCIPAL_INVESTIGATOR