F-18 16 Alpha-Fluoroestradiol for Progesterone Receptor Positive

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Progesterone Receptor Positive+3 MoreF-18 16 Alpha-Fluoroestradiol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study using F-18 16 alpha-fluoroestradiol positron emission tomography/computed tomography to see if it can help predict response to endocrine therapy in patients with newly diagnosed breast cancer.

Eligible Conditions
  • Progesterone Receptor Positive
  • HER2/Neu Negative Breast Cancer
  • Progesterone Receptor Negative Breast Cancer
  • Stage IV Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 1 year

At 6 months
Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease
Baseline
Significance of FES PET measures in predicting PD or CB, in concert with semi-quantitative interpretation of ER, PgR, and Ki-67
Up to 1 year
FES SUVmax < 1.5 as the optimal cutpoint for predicting PFS
Neoplasms
Up to 6 months
FES SUVmax
FES uptake, as measured by SUVmax and semi-quantitative ER from IHC
Heterogeneity of tumor FES uptake in individual patients defined as variability in lesion's FES uptake
Percent of eligible patients for whom biopsy is not feasible, i.e., clinical utility of indirect assay of ER expression by FES PET
Test-retest reproducibility of quantitative assessment of tumor FES uptake by SUVs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Diagnostic (FES PET/CT)
1 of 1

Experimental Treatment

99 Total Participants · 1 Treatment Group

Primary Treatment: F-18 16 Alpha-Fluoroestradiol · No Placebo Group · Phase 2

Diagnostic (FES PET/CT)Experimental Group · 4 Interventions: F-18 16 Alpha-Fluoroestradiol, Computed Tomography, Laboratory Biomarker Analysis, Positron Emission Tomography · Intervention Types: Drug, Procedure, Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Positron Emission Tomography
2008
Completed Phase 2
~2820

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,083 Previous Clinical Trials
41,141,401 Total Patients Enrolled
24 Trials studying Progesterone Receptor Positive
6,103 Patients Enrolled for Progesterone Receptor Positive
Farrokh DehdashtiPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman of childbearing potential and you are sexually active