Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04174352
The ClinicalTrials.gov registry entry for NCT04174352 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 8 other ER+ Breast Cancer trials with a reported enrollment target (86% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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
Similar trials for ER+ Breast Cancer
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.
-
Circulating Tumor DNA
RECRUITING · Phase 2
-
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer
RECRUITING · Phase 2
-
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
RECRUITING · Phase 2
-
Breast Re-irradiation After Second Ipsilateral Lumpectomy
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.