RecruitingPhase 3NCT06195709

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

ECLECTIC: EstroTEP and Circulating Biomarkers to Determine the Optimal Second Line Therapy for ER-positive HER2-negative Metastatic Breast Cancer Patients


Sponsor

Institut Curie

Enrollment

300 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of PET scan (EstroTEP) along with blood biomarkers to predict which patients with hormone receptor-positive (ER+), HER2-negative metastatic breast cancer will respond to hormone-blocking therapies. It aims to help doctors personalize treatment plans. **You may be eligible if...** - You are 18 or older (male or female) - You have metastatic invasive breast cancer that is estrogen receptor-positive (ER+) and HER2-negative - Your life expectancy is greater than 3 months - You are well enough to perform daily activities (ECOG 0–2) - A tumor tissue sample (biopsy block) is available **You may NOT be eligible if...** - Your breast cancer is HER2-positive or ER-negative - You have very poor overall health - You have no available tumor tissue for analysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTEndocrine 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_PRODUCTEndocrine 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_PRODUCTChemotherapy

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(21)

Centre Hospitalier de la Côte basque

Bayonne, France

Institut Bergonié

Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre Georges Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

CHU Limoges

Limoges, France

Centre Leon Bérard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

Institut du Cancer Montpellier

Montpellier, France

Centre Antoine lacassagne

Nice, France

Hôpital Universitaire de Nimes

Nîmes, France

Institut Curie

Paris, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut Curie

Saint-Cloud, France

Bruno MAUCHERAT

Saint-Herblain, France

Centre de lutte contre le cancer Paul Strauss

Strasbourg, France

Oncopole Claudius Regaud

Toulouse, France

Hôpital Bretonneau-CHU Tours

Tours, France

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

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NCT06195709


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