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RECRUITING
NCT06195709
PHASE3

ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients

Sponsor: Institut Curie

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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