OncRef

Clinical Trial: NCT02398773

FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-06-29

Study Overview

Brief Summary

This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.

Official Title

[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer

Conditions

HER2/Neu Negative, Progesterone Receptor Negative, Progesterone Receptor Positive, Stage IV Breast Cancer AJCC v6 and v7

Intervention / Treatment

  • Procedure: Computed Tomography
  • Drug: F-18 16 Alpha-Fluoroestradiol
  • Other: Laboratory Biomarker Analysis
  • Procedure: Positron Emission Tomography

Other Study ID Numbers

  • NCI-2015-00383
  • NCI-2015-00383
  • EAI142
  • PEAI142_R01PAPP01
  • EAI142
  • EAI142
  • U10CA180820

Start Date (Actual)

2016-05-04

Primary Completion Date (Estimated)

2026-12-31

Study Completion Date (Estimated)

2026-12-31

Enrollment (Estimated)

99

Study Type

Interventional

Phase

Phase 2