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Breast CarcinomaPhase 3ECLECTICNCT06195709

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

A Phase 3 study testing Endocrine therapy, Endocrine therapy combined with the local treatment of FES-negative lesions and Chemotherapy in people with Breast Carcinoma, run by Institut Curie at 21 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Carcinoma
What is being tested?
Endocrine therapy, Endocrine therapy combined with the local treatment of FES-negative lesions and Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
21 sitesFrance
Study dates
27 May 2024to 27 Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic invasive breast carcinoma of no special type.
  • Females and males of age ≥18 years.
  • Life expectancy > 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
  • 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.
  • Tumor block Formalin-Fixed Paraffin-Embedded (primary tumor or metastasis) available.
Show all 12Show fewer
  • 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.
  • Patients with available 18F-FDG PET/CT imaging
  • Evaluable disease per RECIST criteria and measurable disease per PERCIST criteria.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations.
  • Signed informed consent.
  • Patient affiliated to a social security system.

Who cannot join

  • Other breast cancer subtype (e.g. invasive lobular breast carcinoma).
  • One or more prior line of chemotherapy in the metastatic setting.
  • Any other systemic treatment given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4/6 inhibitor.
  • Visceral crisis, per investigator's assessment.
  • Liver-only metastases.
  • Prior exposure to any authorized or experimental agent degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc).
Show all 11Show fewer
  • Pregnancy or lactation period.
  • 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.
  • 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.
  • 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-.
  • Persons deprived of their freedom or under guardianship or incapable of giving consent.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

François-Clément BIDARD, PhD contact

+33147111515

francois-clement.bidard@curie.fr

Isabelle TURBIEZ contact

+33156245630

drci.promotion@curie.fr

21 sites in 1 country

France21 sites, 20 recruiting

  • Centre Hospitalier de la Côte basque

    Bayonne, 64100

    Thomas GRELLETY, MD, tgrellety@ch-cotebasque.fr

    Not yet recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Maxime Brunet, MD, m.brunet@bordeaux.unicancer.fr

    Not yet recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

    Laura POETSCH, MD, lpoetsch@gor.bordeauxnord.com

    Not yet recruiting

  • Centre Francois Baclesse

    Caen, 14076

    George EMILE, g.emile@baclesse.unicancer.fr

    Recruiting

  • Centre Georges Francois Leclerc

    Dijon, 21079

    Sylvain LADOIRE, MD, sladoire@cgfl.fr

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Nawale HAJJAJI, MD, n-hajjaji@o-lambret.fr

    Recruiting

  • CHU Limoges

    Limoges, 87000

    Elise DELUCHE, MD, Elise.deluche@chu-limoges.fr

    Not yet recruiting

  • Centre Leon Bérard

    Lyon, 69008

    Sandrine PARISSE-DI MARTINO, MD, sandrine.parisse-dimartino@lyon.unicancer.fr

    Not yet recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Alexandre TASSIN DE NONNEVILLE, MD, tassindenonnevillea@ipc.unicancer.fr

    Recruiting

  • Institut du Cancer Montpellier

    Montpellier, 34298

    Marie ALEXANDRE, MD, Marie.Alexandre@icm.unicancer.fr

    Recruiting

  • Centre Antoine lacassagne

    Nice, 06189

    Olivier Humbert, MD, Olivier.humbert@nice.unicancer.fr

    Recruiting

  • Hôpital Universitaire de Nimes

    Nîmes, 30029

    Frédéric FITENI, MD, frederic.fiteni@chu-nimes.fr

    Not yet recruiting

  • Institut Curie

    Paris, 75005

    Audrey BELLESOEUR, MD, audrey-bellesoeur@curie.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Antoine DELEUZE, MD, a.deleuze@rennes.unicancer.fr

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Florian CLATOT, MD, florian.clatot@chb.unicancer.fr

    Not yet recruiting

  • Institut Curie

    Saint-Cloud, 92210

    François-Clément BIDARD, PhD, francois-clement.bidard@curie.fr

    Recruiting

  • Bruno MAUCHERAT

    Saint-Herblain, 44805

    Withdrawn

  • Centre de lutte contre le cancer Paul Strauss

    Strasbourg

    Thierry PETIT, MD, t.petit@icans.eu

    Not yet recruiting

  • Oncopole Claudius Regaud

    Toulouse, 31059

    Florence DALENC, MD, Dalenc.florence@iuct-oncopole.fr

    Not yet recruiting

  • Hôpital Bretonneau-CHU Tours

    Tours, 37044

    Hélène VEGAS, MD, h.vegas@chu-tours.fr

    Not yet recruiting

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Vincent Massard, MD, v.massard@nancy.unicancer.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Endocrine therapy, Endocrine therapy combined with the local treatment of FES-negative lesions, Chemotherapy
Keywords
Metastatic, PET/CT 18F-FES, Circulating markers
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endocrine therapyCombination product

    Also called Standardized endocrine therapy regimen

    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 lesionsCombination product

    Also called Standardized endocrine therapy regimen

    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.

  • ChemotherapyCombination product

    Also called Standardized chemotherapy regimen

    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.

Study groups in NCT06195709
Study groupRoleWhat they receive
Arm A: Endocrine therapySham comparator1. 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.
Receives: Combination Product: Endocrine therapy; Combination Product: Endocrine therapy combined with the local treatment of FES-negative lesions
Arm B: ChemotherapyActive comparatorAll 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.
Receives: Combination Product: Endocrine therapy; Combination Product: Chemotherapy
Arm C: Endocrine therapyActive comparatorAll 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.
Receives: Combination Product: Endocrine therapy; Combination Product: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is defined as the time from randomization to progression (per RECIST 1.1) or death, among randomized patients.

    Measured: 54 months

Secondary outcomes (10)

  1. Progression-Free survival (PFS)

    PFS is defined as the time from randomization to progression (per PERCIST 1.0) or death, among randomized patients with available Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) evaluation.

    Measured: 54 months

  2. Overall survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause, among randomized patients (arms B and C)

    Measured: 54 months

  3. Objective response rate (ORR)

    ORR is defined as the proportion of patients who have achieved complete response (CR) or partial response (PR) based on local investigator assessment, among randomized patients with measurable disease at baseline,

    Measured: 54 months

  4. Clinical benefit rate (CBR)

    CBR at 24 weeks is defined as the proportion of randomized patients who have achieved either a confirmed complete or partial response, or stable disease for at least 24 weeks after treatment start based on local investigator assessment.

    Measured: 24 weeks

  5. Efficacy criteria: PFS at 24 weeks

    PFS at 24 weeks will be evaluated in patients allocated to arm A.

    Measured: 24 weeks

  6. Efficacy criteria: OS at 24 weeks

    OS at 24 weeks will be evaluated in patients allocated to arm A.

    Measured: 24 weeks

  7. Efficacy criteria: ORR at 24 weeks

    ORR at 24 weeks will be evaluated in patients allocated to arm A.

    Measured: 24 weeks

  8. Efficacy criteria: CBR at 24 weeks

    CBR at 24 weeks will be evaluated in patients allocated to arm A.

    Measured: 24 weeks

  9. Safety and toxicity and their relationship to study treatment

    Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE v5.0

    Measured: 54 months

  10. EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) after 2 months of treatment

    Questionnaire to measure physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items range from 0 to 100. A higher score represents better function and a higher quality of life.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start27 May 2024
  3. Primary completion27 Sep 2029 (estimated)
  4. Study completion27 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06195709
Sponsor's protocol ID
IC 2022-12
Other IDs
2023-506282-66-00, 2023
Acronym
ECLECTIC
Status last verified
Apr 2026
First submitted
7 Dec 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endocrine therapy, Endocrine therapy combined with the local treatment of FES-negative lesions and Chemotherapy in people with Breast Carcinoma, run by Institut Curie at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François-Clément BIDARD, PhD (+33147111515, francois-clement.bidard@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 54 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06195709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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