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NCT01471106 · ClinicalTrials.gov registry record · Phase 2
Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01471106: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01471106 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471106, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if dasatinib can help prevent breast cancer from developing in the unaffected breast. Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Its use in breast cancer patients in investigational. Up to 66 patients will take part in this multicenter study. Up to 60 will be enrolled at MD Anderson.
Primary Outcome
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples. Samples evaluated by immunohistochemistry (IHC). Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
Interventions
- DRUG Dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-01-21 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 2 |
What the finished NCT01471106 record still lists
NCT01471106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Dasatinib is the first listed.
NCT01471106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01471106 about?
NCT01471106 is a clinical study titled "Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer". The goal of this clinical research study is to learn if dasatinib can help prevent breast cancer from developing in the unaffected breast. Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This is an investigatio...
What is the current status of trial NCT01471106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2014-01-21. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT01471106?
The interventions under investigation include: Dasatinib (DRUG).
Who is sponsoring clinical trial NCT01471106?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01471106's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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