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ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients
Sponsor: Institut Curie
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.
Official title: ECLECTIC: EstroTEP and Circulating Biomarkers to Determine the Optimal Second Line Therapy for ER-positive HER2-negative Metastatic Breast Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-05-27
Completion Date
2029-09-27
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Endocrine therapy
Consist in single agent endocrine therapy or in combination with targeted therapy, per guidelines and label. LH-RH agonist will be used in combination with endocrine therapy whenever appropriate and per label.
Endocrine therapy combined with the local treatment of FES-negative lesions
Consist in single agent endocrine therapy or in combination with targeted therapy, per guidelines and label. LH-RH agonist will be used in combination with endocrine therapy whenever appropriate and per label. Cases with only 1 or 2 FES-negative lesions that are accessible to local treatment will be reviewed by the Centralized Reading Committee (including a radiation oncologist) to confirm the feasibility of local treatment.
Chemotherapy
Consist in single agent chemotherapy, poly-chemotherapy, or antibody-drug conjugates, per guidelines and label. Patients who are eligible (per drug label) may receive PARP inhibitor if allocated to Arm B.
Locations (13)
Institut Bergonié
Bordeaux, France
Centre Francois Baclesse
Caen, France
Centre Georges Francois Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Leon Bérard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Institut du Cancer Montpellier
Montpellier, France
Centre Antoine lacassagne
Nice, France
Institut Curie
Paris, France
Centre Eugène Marquis
Rennes, France
Institut Curie
Saint-Cloud, France
Bruno MAUCHERAT
Saint-Herblain, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France