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NCT01313039 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
A Early Phase 1 study, sponsored by University of Miami.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT01313039: Completed Early Phase 1 study, sponsored by University of Miami.
NCT01313039 is a Early Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 4 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313039, a Early Phase 1 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.
Primary Outcome
To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.
Interventions
- DRUG AZ6244
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-04 |
| Phase | Early Phase 1 |
What the finished NCT01313039 record still lists
NCT01313039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which AZ6244 is the first listed.
NCT01313039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313039 about?
NCT01313039 is a clinical study titled "Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer". If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in i...
What is the current status of trial NCT01313039?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2011-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01313039?
The interventions under investigation include: AZ6244 (DRUG).
Who is sponsoring clinical trial NCT01313039?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01313039's enrollment target sits among peer trials
4 1921st of 2000 higher than 53 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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