Triple Negative Breast Cancer Biomarker Study
Public ClinicalTrials.gov record NCT01111175. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01111175
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 14 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2010
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
- Last update posted
- Jul 22, 2013
2010 – 2013
United States locations
- U.S. sites
- 18
- U.S. states
- 6
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | — |
| Virginia Oncology Assocites | Elizabeth City | North Carolina | 27909 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97213 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97225 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | — |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | — |
| Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology-Memorial City | Houston | Texas | 77024 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | — |
| Virginia Oncology Associates | Hampton | Virginia | 23666 | — |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | — |
| Virginia Oncology Associates | Williamsburg | Virginia | 23188 | — |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | — |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98686 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01111175, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2013 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01111175 live on ClinicalTrials.gov.