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.
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
- Are there results?
- Not yet: the study is under way
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.
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
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group, Keosys
- Responsible party
- Sponsor
- Investigators
- Alexandre Cochet, Principal investigator, Centre Georges Francois Leclerc
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05486182
- Acronym / sponsor ID
- ESTROTIMP / ZX-2021-FES-ESTROTIMP-4
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group, Keosys
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective population | Experimental | Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F Fluoroestradiol Radiopharmaceutical with PET/CTAlso: ESTROTEPAdministration of one dose of 18F FES for PET/CT imaging | Drug | Prospective population |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Cochet principal investigator
Centre Georges Francois Leclerc
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.