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NCT00894504 · ClinicalTrials.gov registry record · Phase 2
Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 17
- Study locations
NCT00894504: Completed Phase 2 study of Metastatic Breast Cancer, sponsored by SCRI Development Innovations.
NCT00894504 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by SCRI Development Innovations. The registered enrollment target is 71 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (65% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00894504, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 17
- Study locations
Study Summary
In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.
Primary Outcome
Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG Panitumumab
Study Locations (17)
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Family Cancer Center - Collierville
- Tennessee Oncology - Nashville
Florida
- Aventura Hospital and Medical Center - Aventura
- Florida Cancer Specialists - Fort Myers
Maryland
- Center for Cancer and Blood Disorders - Bethesda
- National Capital Clinical Research Consortium - Bethesda
Missouri
- St. Louis Cancer Care - Chesterfield
- Research Medical Center - Kansas City
California
- Los Robles - Thousand Oaks
Indiana
- Providence Medical Group - Terre Haute
Kentucky
- Norton Cancer Institute - Louisville
Nebraska
- Nebraska Methodist Cancer Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00894504 record still lists
NCT00894504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT00894504 lists 17 locations in 12 states (Tennessee, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT00894504 about?
NCT00894504 is a clinical study titled "Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer". In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of ...
What is the current status of trial NCT00894504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2010-02. Estimated completion is 2014-09.
What conditions does trial NCT00894504 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT00894504?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Panitumumab (DRUG).
Who is sponsoring clinical trial NCT00894504?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00894504 being conducted?
This trial has 17 study locations across California, Florida, Indiana, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00894504's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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