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

NCT ID: NCT06195709

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-27

Study Completion Date

2029-09-27

Brief Summary

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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

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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.

Conditions

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Breast Carcinoma

Keywords

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Metastatic PET/CT 18F-FES Circulating markers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized, multicentric, open-label, phase III trial conducted in patients with ER+ HER2- metastatic breast cancer progressing on first line treatment with CDK4/6 inhibitor and aromatase inhibitor, and which aims at evaluating the combined value of 18F-FES PET/CT and circulating biomarkers to guide second line treatment decision between investigator's choice second line endocrine therapy (with or without targeted therapy) and chemotherapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Endocrine therapy

1. Patients in whom all tumor sites display a FES SUVmax ≥2 AND who have low levels of circulating tumor biomarkers will be treated with endocrine therapy.
2. Patients in whom 18F-FES PET shows an heterogenous uptake, with one or maximum two tumor sites with low FES uptake (SUVmax \<2) that represent less than 20% of all tumor sites and are deemed accessible to local treatment (e.g. stereotactic radiation therapy or another equivalent local therapy) will be treated, if they have low levels of circulating tumor biomarkers, by 2nd line endocrine therapy in Arm A, combined with the local treatment of FES-negative lesions.

Group Type SHAM_COMPARATOR

Endocrine therapy

Intervention Type COMBINATION_PRODUCT

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

Intervention Type COMBINATION_PRODUCT

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.

Arm B: Chemotherapy

All other patients, i.e. (i) patients in whom most or ≥3 lesions display a FES SUVmax \<2 that are not amenable to local treatment, (ii) patients with high levels of circulating tumor biomarkers, will be randomized between chemotherapy in Arm B and endocrine therapy in Arm C.

Group Type ACTIVE_COMPARATOR

Endocrine therapy

Intervention Type COMBINATION_PRODUCT

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.

Chemotherapy

Intervention Type COMBINATION_PRODUCT

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.

Arm C: Endocrine therapy

All other patients, i.e. (i) patients in whom most or ≥3 lesions display a FES SUVmax \<2 that are not amenable to local treatment, (ii) patients with high levels of circulating tumor biomarkers, will be randomized between chemotherapy in Arm B and endocrine therapy in Arm C.

Group Type ACTIVE_COMPARATOR

Endocrine therapy

Intervention Type COMBINATION_PRODUCT

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.

Chemotherapy

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Standardized endocrine therapy regimen Standardized endocrine therapy regimen Standardized chemotherapy regimen

Eligibility Criteria

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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.
11. Signed informed consent.
12. Patient affiliated to a social security system.

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.
9. Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Patients with a history of CNS metastases or cord compression are eligible if they have been treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable and off anticonvulsants and steroids for at least 4 weeks before treatment start.
10. History of previous cancer or hematological malignancy within 3 years preceding patient enrollment in the trial. Multiple primary breast cancers (controlateral/ipsilateral cancers/local relapses) are allowed pending all tumors were ER+ HER2-.
11. Persons deprived of their freedom or under guardianship or incapable of giving consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zionexa

INDUSTRY

Sponsor Role collaborator

Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Le GOUILL, PhD

Role: STUDY_DIRECTOR

Institut Curie

Locations

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Institut Bergonié

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Centre Francois Baclesse

Caen, , France

Site Status NOT_YET_RECRUITING

Centre Georges Francois Leclerc

Dijon, , France

Site Status NOT_YET_RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status NOT_YET_RECRUITING

Centre Leon Bérard

Lyon, , France

Site Status RECRUITING

Institut Paoli-Calmettes

Marseille, , France

Site Status RECRUITING

Institut du Cancer Montpellier

Montpellier, , France

Site Status RECRUITING

Centre Antoine lacassagne

Nice, , France

Site Status NOT_YET_RECRUITING

Institut Curie

Paris, , France

Site Status RECRUITING

Centre Eugène Marquis

Rennes, , France

Site Status NOT_YET_RECRUITING

Institut Curie

Saint-Cloud, , France

Site Status RECRUITING

Bruno MAUCHERAT

Saint-Herblain, , France

Site Status WITHDRAWN

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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François-Clément BIDARD, PhD

Role: CONTACT

Phone: +33147111515

Email: [email protected]

Isabelle TURBIEZ

Role: CONTACT

Phone: +33156245630

Email: [email protected]

Facility Contacts

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Maxime Brunet, MD

Role: primary

George EMILE

Role: primary

Sylvain LADOIRE, MD

Role: primary

Nawale HAJJAJI, MD

Role: primary

Sandrine PARISSE-DI MARTINO, MD

Role: primary

Alexandre TASSIN DE NONNEVILLE, MD

Role: primary

Marie ALEXANDRE, MD

Role: primary

Olivier Humbert, MD

Role: primary

Audrey BELLESOEUR, MD

Role: primary

Antoine DELEUZE, MD

Role: primary

François-Clément BIDARD, PhD

Role: primary

Vincent Massard, MD

Role: primary

Other Identifiers

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2023-506282-66-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

IC 2022-12

Identifier Type: -

Identifier Source: org_study_id