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NCT04174352 · ClinicalTrials.gov registry record · Early Phase 1
FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer
A Early Phase 1 study of ER+ Breast Cancer and ESR1 Gene Mutation, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT04174352: Recruiting Early Phase 1 study of ER+ Breast Cancer and ESR1 Gene Mutation, sponsored by University of Wisconsin, Madison.
NCT04174352 is a Early Phase 1 study of ER+ Breast Cancer and ESR1 Gene Mutation that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 12 participants, below the 88-participant average among 8 other ER+ Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04174352, a Early Phase 1 study of ER+ Breast Cancer and ESR1 Gene Mutation, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always "turned on" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. \[18F\]-fluoroestradiol Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.
Primary Outcome
Reduction in FES uptake will be described and analyzed by Fisher's exact test. Rates or proportion of responses at each dose level will be provided in data listings. If the SUVmax for all 5 target lesions have decreased by \> 75% or all 5 lesions have SUVmax\<1.5 on the second scan, then these participants will be prospectively defined as having complete FES blockade. If the SUVmax for any of the 5 lesions has not decreased by \> 75% or if any new lesions arise with SUVmax ≥1.5, then these subje
Conditions Studied
Interventions
- DRUG Tamoxifen
- DIAGNOSTIC_TEST FES PET/CT
Study Locations (2)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
- Wisconsin Oncology Network (WONIX) sites - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2027-12 |
| Phase | Early Phase 1 |
What NCT04174352 shows while recruiting
NCT04174352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 88-participant average among 8 other ER+ Breast Cancer trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with ER+ Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Tamoxifen is the first listed.
NCT04174352 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04174352 about?
NCT04174352 is a clinical study titled "FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer". Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always "turned on" despite the absence of estrog...
What is the current status of trial NCT04174352?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2020-10-20. Estimated completion is 2027-12.
What conditions does trial NCT04174352 study?
This clinical trial studies the following conditions: ER+ Breast Cancer, ESR1 Gene Mutation.
What interventions are being tested in trial NCT04174352?
The interventions under investigation include: Tamoxifen (DRUG), FES PET/CT (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04174352?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04174352 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04174352's enrollment target sits among peer trials
12 9th of 8 the lowest of 8 other ER+ Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ER+ Breast Cancer 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.
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