ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Can… (NCT06195709) | Clinical Trial Compass
RecruitingPhase 3
ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients
France300 participantsStarted 2024-05-27
Plain-language summary
Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography/Computed Tomography (PET/CT) results and circulating tumor biomarkers, clinicians will decide which treatment to use.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Metastatic invasive breast carcinoma of no special type.
✓. Females and males of age ≥18 years.
✓. Life expectancy \> 3 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
✓. Estrogen Receptor (ER)-positive (≥10%) and HER2-negative (ASCO/College of American Pathologists guidelines) breast cancer, per local assessment on the most recent breast cancer tissue examined.
✓. Tumor block Formalin-Fixed Paraffin-Embedded (primary tumor or metastasis) available.
✓. Patients whose disease has progressed on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor and who are deemed eligible, per investigator assessment, to a second line endocrine therapy. The progression on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor must have occurred after more than 6 months on treatment.
✓. Patients with available 18F-FDG PET/CT imaging
Exclusion criteria
✕. Other breast cancer subtype (e.g. invasive lobular breast carcinoma).
✕. One or more prior line of chemotherapy in the metastatic setting.
✕. Any other systemic treatment given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4/6 inhibitor.
✕. Prior exposure to any authorized or experimental agent degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc).
✕. Pregnancy or lactation period.
✕. In women of childbearing potential or premenopausal women or women with amenorrhea of less than 12 months, without adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization; LH-RH agonist cannot be considered as an efficient contraceptive measure), positive urinary or serum pregnancy test 72 hours before 18F-FES PET/CT.