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 (EstroTEPCompar)

February 12, 2024 updated by: Centre Georges Francois Leclerc

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 Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of this pilot study is to determine the unconformity rates for estrogen receptor expression in different metastatic lesions in patients with first metastatic recurrence of breast cancer initially expressing estrogen receptors.

Secondary objectives are:

  1. To study the influence of the FES PET could have for possible modifications of therapeutic management in these patients.
  2. Determine the rate of patients with additional positive FES lesions but without positive FDG lesions.
  3. Evaluate the response to chemotherapy at 3 months after using FDG-PET in clinical routine.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Claire Tabouret-Viaud, MD
  • Phone Number: + 33 3 80 73 75 22
  • Email: ctabouret@cgfl.fr

Study Contact Backup

Study Locations

  • France
      • Dijon, France, 21079
        • Not yet recruiting
        • CGFL
        • Contact:
        • Contact:
    • Bourgogne
      • Dijon, Bourgogne, France, 21000
        • Recruiting
        • Centre Georges-François Leclerc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ECOG score (Eastern Cooperative Oncology Group) ≤ 2.
  2. Stage IV breast cancer (AJCC TNM).
  3. Primitive tumor expressing RO (> 10%).
  4. Patient candidate for hormone therapy treatment targeting estrogen receptors as a first-line treatment in a context of first metastatic recurrence.
  5. No overexpression of HER2 in the tumor.
  6. Lack of previous treatment for metastatic disease
  7. Metastatic status confirmed by 18F-FDG PET / CT performed in the month prior to inclusion
  8. Life expectancy estimated at more than 3 months.
  9. Patient able to understand and give informed informed consent for participation in the study.
  10. Patient affiliated with the social security scheme or equivalent.

Exclusion Criteria:

  1. Triple negative breast cancer
  2. Overexpression HER2 +++
  3. Metastatic involvement exclusively in the liver
  4. Unable to lie down or maintain the position during the PET / CT scan
  5. Uncontrolled intercurrent pathology that is life-threatening in the short term
  6. Uncontrolled diabetes
  7. History of an allergic reaction attributed to a chemical or biological compound related to FDG or FES
  8. Psychiatric impairment or social conditions that would limit patient availability and compliance at different stages of the study.
  9. Pregnant woman (mandatory pregnancy test at baseline) or who is breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FES PET
1 ) inclusion; 2 ) FGD PET / FES PET; 3) Hormone therapy
Other: FES PET
FES injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estrogen Receptor Gene Expression
Time Frame: at the inclusion
number of FDG+ / FES- lesions compared to the number of FDG+ / FES+ lesions
at the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2021

Primary Completion (Estimated)

October 18, 2025

Study Completion (Estimated)

October 18, 2025

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EstroTEP COMPARE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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