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RECRUITINGPHASE3

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

NCT06195709•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.

Detailed Description

All patients deemed eligible for a second line endocrine therapy will undergo a 18F-FES PET/CT scan and circulating tumor biomarkers assessment (circulating tumor cells (CTC) and, if not available, circulating tumor DNA (ctDNA)). All 18F-FES PET/CT scan will be anonymized and reviewed centrally, and compared to the 18Fluorodeoxyglucose (18F-FDG) PET/CT results before treatment initiation; circulating biomarkers status will be assessed centrally and will remain blinded to investigator and patients. Endocrine therapy in Arm A and C may consist in single agent endocrine therapy or in combination with targeted therapy. Luteinizing Hormone-Releasing Hormone (LH-RH) agonist will be used in combination with endocrine therapy whenever appropriate and per label. Chemotherapy in Arm B may consist in single agent chemotherapy, poly-chemotherapy, or antibody-drug conjugates. Patients who are eligible (per drug label) may receive Poly-adenosine-5'-diphosphate-ribose Polymerase (PARP) inhibitor if allocated to Arm B.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Metastatic invasive breast carcinoma of no special type.
•2. Females and males of age ≥18 years.
•3. Life expectancy \> 3 months.
•4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
•5. 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.
•6. Tumor block Formalin-Fixed Paraffin-Embedded (primary tumor or metastasis) available.
•7. 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.
•8. Patients with available 18F-FDG PET/CT imaging
•9. Evaluable disease per RECIST criteria and measurable disease per PERCIST criteria.
•10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations.
+4 more criteria

Exclusion Criteria

•1. Other breast cancer subtype (e.g. invasive lobular breast carcinoma).
•2. One or more prior line of chemotherapy in the metastatic setting.
•3. Any other systemic treatment given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4/6 inhibitor.
•4. Visceral crisis, per investigator's assessment.
•5. Liver-only metastases.
•6. Prior exposure to any authorized or experimental agent degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc).
•7. Pregnancy or lactation period.
•8. 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.

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

Key Dates

Start Date

May 27, 2024

Primary Completion Date

September 27, 2028

Completion Date

September 27, 2029

Last Updated

December 18, 2025

Enrollment

300

ESTIMATED participants

Conditions

Breast Carcinoma

Interventions

Endocrine therapy

COMBINATION_PRODUCT

Endocrine therapy combined with the local treatment of FES-negative lesions

COMBINATION_PRODUCT

Chemotherapy

COMBINATION_PRODUCT

Contacts

François-Clément BIDARD, PhD

CONTACT

+33147111515 francois-clement.bidard@curie.fr

Isabelle TURBIEZ

CONTACT

+33156245630 drci.promotion@curie.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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