NCT05486182Active, not recruitingPhase 4
Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 153 (actual)
- First submitted
- 4 Mar 2022
- Start date
- 8 Feb 2022
- Primary completion date
- 18 Apr 2025
- Lead sponsor
- GE Healthcare
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05486182
- EU CT number
- 2024-517400-11-00
- EudraCT number
- 2021-003601-21
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 153
- From 8 Feb 2022 to the primary completion date, 18 Apr 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy
Other illness
- 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
- atients suffering from severe or known chronic liver or renal failure
- Severe intercurrent disease or comorbidity assessed at risk
Lab values
- Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion
Age
- Woman of childbearing age with no effective means of contraception according to the investigator's opinion
Other
- Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
- Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Completed |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Completed |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Completed |
| Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Completed |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.