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

Last updated: February 10, 2025
Sponsor: GE Healthcare
Overall Status: Active - Not Recruiting

Phase

4

Condition

Breast Cancer

Metastatic Cancer

Treatment

18F Fluoroestradiol Radiopharmaceutical with PET/CT

Clinical Study ID

NCT05486182
ZX-2021-FES-ESTROTIMP-4
2024-517400-11-00
2021-003601-21
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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-upother than a liver lesion

  5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormonetherapy

  6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment formetastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seekingthe relapse during 2nd line staging (according to the recommendations of the Guideto Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will berespected 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 lifequestionnaires

Exclusion

Exclusion Criteria:

  1. Isolated hepatic metastases (taking into account the high physiological hepaticuptake of FES)

  2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatmentfor 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 orSERD 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 levelsincompatible with the administration of EstroTep, according to the investigator'sopinion

  7. Woman of childbearing age with no effective means of contraception according to theinvestigator'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 FrenchPublic Health Code

Study Design

Total Participants: 153
Treatment Group(s): 1
Primary Treatment: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Phase: 4
Study Start date:
February 08, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CGFL

    Dijon, 21079
    France

    Site Not Available

  • CHU Grenoble Alpes

    La Tronche, 38700
    France

    Site Not Available

  • CHU de Limoges - Dupuytren

    Limoges, 87000
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69008
    France

    Site Not Available

  • Institut du Cancer de Montpellier

    Montpellier, 34298
    France

    Site Not Available

  • Hôpital Américain de Paris

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Hôpital Tenon

    Paris, 75020
    France

    Site Not Available

  • Institut Curie

    Paris, 75248
    France

    Site Not Available

  • Institut Curie

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut Claudius Regaud Centre de Lutte Contre le Cancer

    Toulouse, 31059
    France

    Site Not Available

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