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NCT02455453 · ClinicalTrials.gov registry record · Phase 2
Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT02455453: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT02455453 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02455453, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the uptake of a radioactive tracer 21-18F-fluoro-16α,17α-\[(R)-(1'-α-furylmethylidene)dioxy\]-19-norpregn-4-ene-3,20-dione (FFNP) uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before and after administration of estradiol for one day (estrogen challenge) to determine if the change in uptake is a predictor of response to endocrine therapy (ET) in patients with hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat metastatic breast cancer. The investigators propose to study patients with biopsy-proven newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as standard of care therapy. Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one immediately following the one day estradiol challenge before the start of standard of care ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.
Interventions
- DRUG 18F-FDG
- DRUG Estradiol
- DRUG 18F-FFNP
- DEVICE CTI/Siemens Biograph 40 PET/CT Scanner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-04-28 |
| Est. Completion | 2019-01-03 |
| Phase | Phase 2 |
What the finished NCT02455453 record still lists
NCT02455453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which 18F-FDG is the first listed.
NCT02455453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02455453 about?
NCT02455453 is a clinical study titled "Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography". The purpose of this study is to evaluate the uptake of a radioactive tracer 21-18F-fluoro-16α,17α-\[(R)-(1'-α-furylmethylidene)dioxy\]-19-norpregn-4-ene-3,20-dione (FFNP) uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before and after administration of estradiol ...
What is the current status of trial NCT02455453?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2015-04-28. Estimated completion is 2019-01-03.
What interventions are being tested in trial NCT02455453?
The interventions under investigation include: 18F-FDG (DRUG), Estradiol (DRUG), 18F-FFNP (DRUG), CTI/Siemens Biograph 40 PET/CT Scanner (DEVICE).
Who is sponsoring clinical trial NCT02455453?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02455453's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 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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