TheranosticTrials.org

Clinical Trial · NCT03442504

Prediction of Response to 2nd-line Hormone Therapy by FES CT/PET in Patients With Metastatic Breast Cancer

Overview

Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas. Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.

Sponsor

Institut Cancerologie de l'Ouest

Phase

N/A

Contacts

Caroline ROUSSEAU, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03442504

Drug / Compound

FES

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

Eligibility

Inclusion

  • Primary breast tumor (ductal or lobular) expressing immunohistochemistry of hormone receptors (RP + and / or RE +, with significance level ≥ 10%) but not overexpressing HER2,
  • Creatinine \<= 2.5 normal
  • Patient progressing under a 1st line of hormone therapy,
  • Karnofsky ≥ 70 or ECOG 0-1
  • Metastatic stage with at least one lesion identifiable on the conventional balance sheet other than a liver injury,
  • Postmenopausal patient,
  • Patient candidate for a new second-line hormonal treatment,

Exclusion

  • Tumor that does not significantly (\<10%) express the hormonal receptors,
  • HER2 overexpressing primary tumor in immunohistochemistry,
  • Patient receiving or likely to receive second-line chemotherapy in the course of the evolution of her breast cancer,
  • Hormonal treatment in progress,
  • Contraindication to a new second-line hormonal treatment,
  • History of cancer within 5 years, with the exception of cutaneous carcinomas other than melanomas, or carcinoma in situ of the cervix,