TheranosticTrials.org

Clinical Trial · NCT03544762

Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation

Overview

The propose of this prospective study focuses on the role of \[18F\]FES PET imaging in patients with breast cancer who might receive or are receiving hormone therapy. First, we will develop and optimize the radiosynthesis and quality control tests of \[18F\]FES in conditions that meet good manufacturing practice (GMP) requirements. Secondly, patients with or without metastatic breast cancer will be enrolled for the conduction of human study. \[18F\]FES PET imaging will be performed on patients before the initiation of hormone therapy to predict the prognosis and therapeutic response to hormone therapy. The \[18F\]FES PET results will be compared with ER status obtained by immunohistochemical (IHC) staining on surgically obtained specimens. Moreover, in patients with progression of metastatic disease, the \[18F\]FES PET will be correlated with ESR1 gene mutation, which is one of the mechanisms for resistance to hormone therapy.

Sponsor

National Taiwan University Hospital

Phase

Phase 3

ClinicalTrials.gov

NCT03544762

Drug / Compound

FES

Isotope(s):
Target(s):
  • Estrogen Receptor
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patients with ESR1 gene analysis
  • Hemoglobin ≥9.0 g/dL
  • ECOG performance status 0 to 2
  • ER status evaluated by immunohistochemical (IHC) staining; Her2 status evaluated by IHC or in-situ hybridization (ISH)
  • Neutrophil count ≥1.5×109/L
  • Life expectancy \>3 months.
  • Liver Function：
  • (1) Albumin \> 25 g/dL
  • Renal Function：Creatinine ≤ 2.0 mg/dL
  • Aspartate transaminase (AST) ≤ 77.5 U/L
  • Total bilirubin level ≤ 1.5 mg/dL
  • Hematologic Function：
  • Platelet count ≥100×109/L
  • alanine transaminase (ALT) ≤ 102.5 U/L
  • Patients will receive hormone therapy as adjuvant therapy or treatment of metastatic disease
  • Patients with breast cancer proven by pathology or cytology

Exclusion

  • Cannot accept 18F-FES PET
  • There are other tumors
  • By doctor evaluation to unsuitable
  • Pregnant or planning pregnant woman
  • Breastfeeding
  • Patients with known secondary malignancy other than breast cancer
  • Patients treated with oral or intravenous cytotoxic agent(s) during the same period of hormone therapy
  • Patients who received neoadjuvant chemotherapy, radiation or hormone therapy before the operation of newly diagnosed breast cancer
  • Patients not suitable for hormone therapy after clinical assessment
  • Unclear consciousness
  • Allergy to drug