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

NCT05486182 | Active Not Recruiting Phase 4

• 3 other identifiers: ZX-2021-FES-ESTROTIMP-42021-003601-212024-517400-11-00
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

Prospective population

EXPERIMENTAL

Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT

Interventions

18F Fluoroestradiol Radiopharmaceutical with PET/CT DRUG

Administration of one dose of 18F FES for PET/CT imaging

Also known as: ESTROTEP

Prospective population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged at least 18 years old at the time of enrolment
• Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)
• HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)
• Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion
• Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy
• 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).
• ECOG 0, 1 or 2
• Life expectancy of at least 12 months
• Patient registered with a Social Security scheme
• Patient having signed an informed consent form
• Patient able to follow the study procedures and fill in the quality of life questionnaires

You may not qualify if:

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

Sponsors & Collaborators

• GE Healthcare: lead
• Simbec-Orion Group: collaborator
• Keosys: collaborator

Study Sites (11)

CGFL

Dijon, 21079, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

CHU de Limoges - Dupuytren

Limoges, 87000, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut du Cancer de Montpellier

Montpellier, 34298, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, 92200, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Institut Curie

Paris, 75248, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Institut Claudius Regaud Centre de Lutte Contre le Cancer

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alexandre Cochet

  Centre Georges Francois Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: August 3, 2022
• Study Start: February 8, 2022
• Primary Completion: April 18, 2025
• Study Completion: January 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

FR (11)