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NCT01307891 · ClinicalTrials.gov registry record · Phase 2
Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01307891 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 64 participants.
The verdict
NCT01307891, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in American women. Metastatic disease including metastatic breast cancer unfortunately remains incurable. One reason is due to the inability to develop specific therapies for specific cancer subsets. The use of modern genomic techniques has significantly enhanced our recent understanding of breast cancer biology. Five distinct breast cancer subsets have been recognized, one of which is basal-like breast cancer. Basal-like breast cancer is typically estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER-2-Neu) negative. This is referred to as triple negative breast cancer or TBNC. TBNC represents a significant proportion of breast cancer patients (10-20%) and has a poor prognosis with no targeted approach to therapy as of yet. Tigatuzumab is a humanized monoclonal antibody targeting a death receptor on the breast cancer cells. Previous studies have shown that combining antibodies with selected chemotherapy agents have induced tumor cell death. The hypothesis of this study is to use tigatuzumab and combine it with Abraxane to serve as a targeting agent in metastatic TBNC patients.
Interventions
- DRUG Abraxane alone
- DRUG Abraxane + Tigatuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-03 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01307891
The ClinicalTrials.gov registry entry for NCT01307891 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Abraxane alone is the first listed.
NCT01307891 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01307891 about?
NCT01307891 is a clinical study titled "Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer". Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in American women. Metastatic disease including metastatic breast cancer unfortunately remains incurable. One reason is due to the inability to develop specific therapies for specific cancer subsets. T...
What is the current status of trial NCT01307891?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2011-03. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01307891?
The interventions under investigation include: Abraxane alone (DRUG), Abraxane + Tigatuzumab (DRUG).
Who is sponsoring clinical trial NCT01307891?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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