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NCT01111175 · ClinicalTrials.gov registry record
Triple Negative Breast Cancer Biomarker Study
A clinical trial, sponsored by US Oncology Research.
- Completed
- Registry status
- 14
- Enrollment target
NCT01111175: Completed study, sponsored by US Oncology Research.
NCT01111175 is a clinical trial that has completed, run by US Oncology Research. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01111175 has completed, sponsored by US Oncology Research.
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-06 |
What the finished NCT01111175 record still lists
NCT01111175 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 14 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01111175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01111175 about?
NCT01111175 is a clinical study titled "Triple Negative Breast Cancer Biomarker Study". 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. ...
What is the current status of trial NCT01111175?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2010-05. Estimated completion is 2013-06.
Who is sponsoring clinical trial NCT01111175?
This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.
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