TheranosticTrials.org

Clinical Trial · NCT01928186

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

Overview

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.

Sponsor

University of Washington

Phase

N/A

Contacts

Hannah Linden (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01928186

Eligibility

Inclusion

  • Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as
  • A prior documented bilateral oophorectomy, or
  • Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
  • Be a candidate for \[18F\]FLT PET imaging
  • Have tissue block available from core biopsy for correlative biomarkers and genomic assay
  • 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
  • Be willing and able to comply with scheduled visits and other trial procedures
  • A history of at least 12 months without spontaneous menstrual bleeding, or
  • 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
  • A new diagnosis of invasive breast cancer \> 1.0 cm in size, ER+ clinical stage I-III

Exclusion

  • Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
  • Weight exceeding capacity of imaging table
  • HER2/neu positive by IHC and/or another FDA approved HER2 testing method
  • Current use of aromatase inhibitor as prevention or treatment for breast cancer
  • Life expectancy of less than two months