CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Fluorothymidine F-18 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01928186
NCT01928186N/ACompleted
CompareCT.gov

Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET

University of Washington·interventional·Posted Aug 23, 2013·Updated May 15, 2018

In Brief

A clinical study evaluating Fluorothymidine F-18, Positron Emission Tomography, and 2 other interventions for Estrogen Receptor Positive and 9 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2013
Enrollment StartSep 1, 2011
Primary CompletionJul 20, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.9 years ago

Interventions

Fluorothymidine F-18drug

Undergo FLT PET

Positron Emission Tomographyprocedure

Undergo FLT PET

Laboratory Biomarker Analysisother

Correlative studies

Run-in (short pre-surgery course) of endocrine-targeted therapydrug

Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.