ECLECTIC: EstroTEP and Circulating Biomarkers to Determine the Optimal Second Line Therapy for ER-positive HER2-negative Metastatic Breast Cancer Patients
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.
• 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
• Evaluable disease per RECIST criteria and measurable disease per PERCIST criteria.
⁃ Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations.
⁃ Signed informed consent.
⁃ Patient affiliated to a social security system.