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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CGFL, Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

18F Fluoroestradiol Radiopharmaceutical with PET/CT

Drug

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

Other names: ESTROTEP

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

Keosys
Simbec-Orion Group

Registry information

Official study title

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

Acronym: ESTROTIMP

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Aug 3, 2022
Registry last updated: Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting