Patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression of HER2, relapsing after a first therapeutic line combining hormone therapy. MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ESTROTEP 500 MBq/mL, solution injectable
Pharmaceutical Form: Injection
Sponsors
Zionexa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 accepting to perform a PET / CT with the baseline FDG for the extension assessment (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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 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. Woman of childbearing potential without effective contraception 6. Serious intercurrent illness or co-morbidity assessed as risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The therapeutic impact will be assessed by the percentage of patients for whom a substantial therapeutic measure has been implemented following the analysis of the PET-FES examination. This evaluation will be done using a standardized questionnaire filled in by the prescribing clinician prospectively, when requesting PET / CT at FES. This questionnaire will be completed again within a maximum of 15 days after the PET / CT FES in order to specify the final therapeutic measure. The treatment modality initially planned and that finally implemented can be determined in the RCP according to the centers. For the same patient, the questionnaire will be completed by the same investigator. Any modification of: - therapeutic modalities • change in the type of hormone therapy molecule • change in the type of chemotherapy molecule • addition of a systemic treatment molecule • withdrawal of a systemic treatment molecule • addition of radiotherapy treatment • stopping radiotherapy treatment • change in radiotherapy technique • change in radiotherapy protocol • programming of surgery • deprogramming of surgery - diagnostic modalities: • addition of a complementary exam • withdrawal of an additional examination • performing a biopsy - monitoring methods • adding an exam • withdrawal of an exam • increased frequency of follow-up • decrease in frequency of follow-up The other therapeutic measures will not be considered as substantial: - changes in processing methods • increase in dosage • decrease in dosage • increase in duration • reduction in duration - changes to the radiotherapy protocol: enlarged or restricted irradiation field of an already identified area ;Timepoint(s) of evaluation of this end point: After FES PET/CT (30 days max after inclusion);Main Objective: To assess the impact of FES PET / CT on the management of patients with metastatic breast cancer initially presenting with overexpression of estrogen receptors (ERs) and absence of overexpression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Primary secondary endpoints - 2nd line progression-free survival (PFS) is defined as the time between the date of the final therapeutic measure and relapse, by comparing the medians of progression-free survival (PFS) in the study population and in the cohort historical. The comparison will be made by the Kaplan Meier test with a 12-month censorship. - The relevance of the therapeutic measures put in place following the baseline PET / CT FES will be determined at 3 months on all the data in the patient's medical file (including the evaluation of the response to treatment) of the patient by an independent jury clinicians, made up of multidisciplinary members (an oncologist, a nuclear physician and a radiotherapist). ;Timepoint(s) of evaluation of this end point: -At 12 months -At 3 months | — |
Countries
France
Contacts
Public ContactClinical Trial Information
Zionexa
Outcome results
None listed