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Impact of 18F-FES TEP on therapeutical management in patients with metastatic breast cancer, ER positive and HER2 negative, in relapse after a first line of treatment combining hormonal therapy
EU CTIS ID: 2024-517400-11-00
What this study is testing
To assess the impact of FES PET/CT on the management of patients with metastatic breast cancer initially presenting with overexpression of oestrogen receptors (ER) and absence of HER2 overexpression, in relapse after first-line treatment combining hormone therapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Woman aged at least 18 years old on inclusion 2. Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%) 3. Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative) 4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a hepatic lesion 5. Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy 6.Patient having performed a PET / CT with FDG during the follow-up of the first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES). 7.ECOG 0, 1 or 2 8. Life expectancy of at least 12 months
You likely can't join if
- 1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES) 2. Patients in the first metastatic line or beyond the second metastatic line 3. Person with a known allergy to any of the components of EstroTep 4. Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD 5. Patient suffering from severe or known hepatic or renal failure 6. Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment 7.Woman of childbearing potential without effective contraception according to the investigator judgement 8. Serious intercurrent illness or co-morbidity assessed as risk
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.