Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer (ESTROTIMP)

August 11, 2025 updated by: GE Healthcare

Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Patients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy

This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).

Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.

After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators.

Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • France
      • Dijon, France, 21079
        • CGFL
      • La Tronche, France, 38700
        • CHU Grenoble Alpes
      • Limoges, France, 87000
        • Chu de Limoges - Dupuytren
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Montpellier, France, 34298
        • Institut du Cancer de Montpellier
      • Neuilly-sur-Seine, France, 92200
        • Hopital Americain de Paris
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75248
        • Institut CURIE
      • Paris, France, 75020
        • Hôpital Tenon
      • Saint-Cloud, France, 92210
        • Institut CURIE
      • Toulouse, France, 31059
        • Institut Claudius Regaud Centre de Lutte Contre le Cancer

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. Female aged at least 18 years old at the time of enrolment
  2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)
  3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)
  4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion
  5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy
  6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES).
  7. ECOG 0, 1 or 2
  8. Life expectancy of at least 12 months
  9. Patient registered with a Social Security scheme
  10. Patient having signed an informed consent form
  11. Patient able to follow the study procedures and fill in the quality of life questionnaires

Exclusion Criteria:

  1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
  2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer
  3. Person presenting a known allergy to one of the components of EstroTep
  4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy
  5. atients suffering from severe or known chronic liver or renal failure
  6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion
  7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion
  8. Severe intercurrent disease or comorbidity assessed at risk
  9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code

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
Experimental: Prospective population
Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Administration of one dose of 18F FES for PET/CT imaging
Other Names:
  • ESTROTEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy.
Time Frame: Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT

The percentage of patients for whom a substantial therapeutic measure was implemented following an analysis of the FES PET examination. This assessment will be performed prospectively by means of a standardised questionnaire completed by the prescribing clinician, when the request for an FES PET/CT is made. The therapeutic modality initially planned and the modality actually used may be determined by a multidisciplinary consultation meeting depending on the centre. This questionnaire will completed again within a maximum period of 15 days following the FES PET/CT in order to specify the final therapeutic measure.

Substantial measures will be considered to be any major modifications made in terms of: therapeutic modalities, diagnostic modalities and follow-up modalities.
Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT

Collaborators and Investigators

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

Sponsor

GE Healthcare

Collaborators

Simbec-Orion Group
Keosys

Investigators

  • Principal Investigator: Alexandre Cochet, 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)

February 8, 2022

Primary Completion (Actual)

April 18, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZX-2021-FES-ESTROTIMP-4
  • 2021-003601-21 (EudraCT Number)
  • 2024-517400-11-00 (Ctis)

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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