Clinical Trial · NCT03873428

Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of PET With FES

Overview

Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe. Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. The different treatments in metastatic relapse of hormone receptor-positive breast cancer are systemic treatments, such as hormone therapy, chemotherapy, targeted therapies, and possible supportive care, but also in some cases local treatments such as surgery and radiotherapy. Comparative analysis of primary mammary tumors and their metastases has demonstrated the essential role of tumor heterogeneity, both in time and space, in the progression of the disease and the occurrence of resistance to treatments. Taking into account this intratumoral heterogeneity represents a major axis of improvement in the management of patients with breast cancer. The use of innovative radiotracers such as 16α- \[18F\] -fluoro-17β-estradiol (FES) may allow in the future to better evaluate this tumor heterogeneity in patients with metastatic breast cancer through non-metastatic characterization. invasive different lesions. It will be possible to propose to each patient a more personalized care with possibly the administration, in addition to the systemic treatment, of a local treatment adapted to the characteristics of some secondary lesions likely to respond less well to the systemic treatment. In this pilot study, the investigators would like to estimate the number of patients and the number of metastatic sites affected by tumor heterogeneity of estrogen receptor expression, which could benefit from specific management. This study will concern a population of patients with first metastatic recurrence of hormone receptor-positive breast cancer initially, with at least one metastasis, who are candidates for treatment with hormone therapy.

Sponsor

Centre Georges Francois Leclerc

Phase

N/A

Contacts

Emilie REDERSTORFF, PhD (CONTACT)

erederstorff@cgfl.fr

+33(0)3 80 73 75 00

Claire Tabouret-Viaud, MD (CONTACT)

ctabouret@cgfl.fr

+ 33 3 80 73 75 22

ClinicalTrials.gov

NCT03873428

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

fluoro-17β-estradiol

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

Eligibility

Inclusion

  • Stage IV breast cancer (AJCC TNM).
  • Lack of previous treatment for metastatic disease
  • No overexpression of HER2 in the tumor.
  • Metastatic status confirmed by 18F-FDG PET / CT performed in the month prior to inclusion
  • Primitive tumor expressing RO (\> 10%).
  • Patient candidate for hormone therapy treatment targeting estrogen receptors as a first-line treatment in a context of first metastatic recurrence.
  • ECOG score (Eastern Cooperative Oncology Group) ≤ 2.

Exclusion

  • Metastatic involvement exclusively in the liver
  • Overexpression HER2 +++
  • Triple negative breast cancer