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Protocol No. EAI142

Principal Investigator Fowler, Amy

Phase II

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed; National

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

Objective The purpose of this research study is to test if an imaging drug, not approved by the Food and Drug Administration (FDA), called FES (fluorodeoxyglucose), is useful for evaluating your type of cancer and predicting how well your cancer responds to therapy. This drug is used with a PET/CT scan. The researchers want to see if the PET/CT scan, using the study drug, can improve upon the usual way of choosing treatment for your type of cancer.

Treatment The experimental parts of this imaging study are the agent called FES and the imaging tests call FES PET/CT. The agent is commonly known as "FES" (18F-Fluoroestradiol), which is a radioactive form of the hormone estrogen. It is a radioactive substance that may "light up" where cancer is in your body.

Description On the day of your scan, a small intravenous (i.v.) catheter will be inserted into a vein of your hand or arm. This i.v. catheter will be used to draw a small blood sample (less than 1 teaspoon) to check the amount of sugar (glucose) present in your blood stream. If your blood sugar is okay, you will receive a small injection of the radioactive drug FDG (a radioactive form of sugar). The FDG will need to circulate around in your body for 50 - 70 minutes before your scan. . FDG travels to places in the body where glucose is used for energy. It shows up in cancer because cancer cells use more glucose than normal tissues.. About 10 - 30 minutes after you have been given the FDG, you may be asked to drink approximately 20 ounces of an FDA-approved oral contrast material used in CT scanning that makes it easier to see your intestines on the pictures. About 30 minutes after you drink the oral contrast you will be asked to lie on your back on the PET imaging table for pictures. The total amount of time you will need for the FDG PET/CT scan is approximately 2 - 3 hours.

Key Eligibility
  • Patient must be a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor, with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed
  • Histologically confirmed metastatic breast cancer
  • Primary tumor and/or metastatic site must be ER+ and may be progesterone-receptor positive (PgR+) or progesterone-receptor negative (PgR-)Patients with a history of an estrogen-receptor negative (ER-) primary tumor and a documented ER+ metastatic site are eligible
  • Patient must NOT have (HER2+) metastatic disease
  • Patient must NOT have received prior endocrine therapy for metastatic disease
  • Patient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapy
  • Patient must NOT have a history of >1 line of administered chemotherapy for metastatic disease

Applicable Disease Sites Breast

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park