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Spots Global Cancer Trial Database for Triple Negative Breast Cancer Biomarker Study

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Triple Negative Breast Cancer Biomarker Study

Official Title: Triple Negative Breast Cancer Biomarker Study

Study ID: NCT01111175

Interventions

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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