FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

• Status: Completed
• Trial end date: 2015-07-20
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alovudine

Criteria

Inclusion Criteria:

• A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III

• Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study

• Have tissue block available from core biopsy for correlative biomarkers and genomic assay

• Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as

• A prior documented bilateral oophorectomy, or

• A history of at least 12 months without spontaneous menstrual bleeding, or

• Age 60 or older with a prior hysterectomy without oophorectomy, or

• Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab

• Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients

• Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed

• Be a candidate for [18F]FLT PET imaging

• Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures

• Be willing and able to comply with scheduled visits and other trial procedures

Exclusion Criteria:

• Current use of aromatase inhibitor as prevention or treatment for breast cancer

• Life expectancy of less than two months

• HER2/neu positive by IHC and/or another FDA approved HER2 testing method

• Inability to tolerate scanning (e.g. - claustrophobia, severe pain)

• Weight exceeding capacity of imaging table