Triple Negative Breast Cancer Biomarker Study



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010

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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.



We found this trial at
9
sites
Norfolk, Virginia 23502
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Norfolk, VA
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Austin, TX
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Bedford, Texas 76022
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Bedford, TX
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Dallas, Texas 75246
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Dallas, TX
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Denver, Colorado 80218
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Denver, CO
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Elizabeth City, North Carolina 27909
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Elizabeth City, NC
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Tyler, Texas 75702
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Tyler, TX
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Vancouver, Washington 98686
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Vancouver, WA
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Vancouver, WA
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