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SCCA Breast Cancer Clinical Trials

FES Imaging in Response to Hormone Therapy (6357)
A Phase 2 Study of [18F]fluoroestradiol (FES) Imaging and Response to Hormonal Therapy
Status Conditions Phase Study ID
Recruiting Breast Cancer Phase II 6357
Summary

The purpose of this study is to measure the amount of estrogen receptor in your breast cancer using an imaging procedure called positron emission tomography (PET). PET is a type of radiologic scan that uses a large donut shaped detection device to pick up tiny radiation signals given off by a radioactive tracer. In this study we will use [18F]fluoroestradiol (FES), a specialized radioactive PET tracer used to detect estrogen receptors. FES PET has been validated as a measure of estrogen receptor expression and we will test the value of FES on helping us to evaluate response to hormonal therapy.

All patients who participate in this study must have recurrent or metastatic breast cancer from an estrogen receptor positive (ER+) primary tumor and be undergoing endocrine-targeted therapy. All patients will have a clinical [18F]Fluordeoxyglucose (FDG) PET scan. The FDG PET uses [18F]Fluordeoxyglucose, a radioactive tracer that allows us to see how tumors metabolize glucose, a sugar. The FDG PET is normally done in breast cancer patients as part of normal clinical care, but may be done as a research scan if the patient has undergone a recent FDG PET at an outside institution or if they are unable to obtain a clinical FDG PET scan. In addition, all patients will have a pre-therapy research FES PET at the University of Washington Medical Center (UWMC) before starting their new treatment with endocrine-targeted therapy. In some patients receiving non-interfering medications such as aromatase inhibitors, scans may be performed with patients already on treatment who will begin an alternative or additional endocrine treatment, such as fulvestrant. A blood sample will be drawn on the same day as the FES PET scan.

Patients who are willing to tolerate repeat imaging will undergo a 2nd FES PET between 2-10 weeks depending upon the endocrine regimen to assess the effect of therapy on estrogen receptor (ER) expression and estradiol binding to the receptors. Clinical follow up will continue for a minimum of 6 months following the FES PET scan or until disease progression. During this 6 month window we will repeat blood draws at 12 weeks and 6 months post FES PET, as well as any conventional imaging (CT, MRI, Bone Scan or other), as deemed appropriate by treating physicians. In addition, we will ask for permission to have access to medical information related to cancer treatment for up to 15 years after the FES PET scan.
 


Investigator
David Mankoff, M.D., PhD Hannah Linden, MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)

DISEASE CHARACTERISTICS:
Inclusion criteria
• Biopsy-proven or clinically obvious breast cancer
• Positive for estrogen receptor (ER) expression in the primary tumor and/or metastatic site.
• At least one site of disease ≥ 1.5 cm

PATIENT CHARACTERISTICS:
Inclusion criteria
• Menopausal status documented
• Willing to undergo imaging procedures. Select patients will return for serial imaging
• Must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks.
• Plan to have hormonal therapy regimen for treatment of their breast cancer
 

Exclusions (conditions that would prevent participation in this study)

• Pregnant or lactating
• Inability to tolerate scanning (e.g. - claustrophobia, severe pain).
• Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)
• Use of tamoxifen, faslodex, DES or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan.
 

Last Updated
March 24, 2011
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.