NCT00602043

F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer

A Phase 2 Study of [18F] Fluoroestradiol (FES) as a Marker of Hormone Sensitivity of Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women with hormone receptor-positive metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how well patients will respond to hormone therapy and may help plan the best treatment.

Detailed description

PRIMARY OBJECTIVES: I. Estimate the ability of \[\^18F\] FES positron emission tomography (PET) or PET/computed tomography (CT) uptake at the level of standard uptake value (SUV) \< 1.5 to predict overall response (OR) to first line endocrine therapy for metastatic breast cancer. SECONDARY OBJECTIVES: I. Evaluate the independent role of \[\^18F\] FES in predicting response and time to progression in patients treated with first-line endocrine therapy for metastatic breast cancer. II. Examine the role of \[\^18F\] FES in predicting OR or clinical benefit (CB), in concert with tissue assay of levels of estrogen receptor (ER) messenger ribonucleic acid (mRNA) measured using quantitative polymerase chain reaction (PCR), and semi-quantitative interpretation of estrogen receptor (ER), progesterone receptor (PgR), androgen receptor (AR), and human epidermal growth factor-2 (HER2), in addition to serial measures of hormone levels in plasma. III. Evaluate the relationships among \[\^18F\] FES, semi-quantitative ER from immunohistochemistry (IHC), and ER mRNA as measured by quantitative PCR. IV. Document the safety profile of \[\^18F\] FES PET in newly diagnosed patients with metastatic breast cancer. V. Evaluate FES SUV \< 1.5 as the optimal cutpoint for predicting OR to first-line endocrine therapy for metastatic breast cancer. VI. Estimate the rate of \[\^18F\] FES SUV \< 1.5 in newly diagnosed metastatic breast cancer patients planning a course of endocrine therapy. OUTLINE: Patients undergo \[\^18F\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \[\^18F\] FES PET scan. After completion of study treatment, patients are followed up for at least 6 months.

Conditions

• Estrogen Receptor-positive Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Progesterone Receptor-positive Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
RADIATION	F-18 16 alpha-fluoroestradiol	Undergo \[\^18F\] FES PET
RADIATION	fludeoxyglucose F 18	Undergo standard clinical FDG PET/CT
PROCEDURE	positron emission tomography	Undergo \[\^18F\] FES PET
PROCEDURE	positron emission tomography	Undergo standard clinical FDG PET/CT
PROCEDURE	computed tomography	Undergo standard clinical FDG PET/CT
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-08-01
• Completion: 2014-09-01
• First posted: 2008-01-28
• Last updated: 2020-02-19
• Results posted: 2014-12-25

Locations

1 site across 1 country: United States