Metastatic Breast CancerPhase 4ESTROTIMPNCT05486182

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

A Phase 4 study testing 18F Fluoroestradiol Radiopharmaceutical with PET/CT in people with Metastatic Breast Cancer, run by GE Healthcare at 11 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
What is being tested?: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 11 sitesFrance
Study dates: 8 Feb 2022to Jan 2026
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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

Who cannot join

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

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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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

France11 sites

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

Other trials in France

About this study

Official 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

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
Being tested: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F Fluoroestradiol Radiopharmaceutical with PET/CTDrug
Also called ESTROTEP
Administration of one dose of 18F FES for PET/CT imaging

Study groups in NCT05486182
Study group	Role	What they receive
Prospective population	Experimental	Not described Receives: Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 2022Jan 2026

First posted3 Aug 2022
Study start8 Feb 2022
Primary completion18 Apr 2025
Study completionJan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05486182
Sponsor's protocol ID: ZX-2021-FES-ESTROTIMP-4
Other IDs: 2021-003601-21, 2024-517400-11-00
Acronym: ESTROTIMP
Status last verified: Aug 2025
First submitted: 4 Mar 2022
Last updated: 14 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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