NCT06195709

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
53mo left

Started May 2024

Longer than P75 for phase_3

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
May 2024Sep 2030

First Submitted

Initial submission to the registry

December 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 27, 2024

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2030

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

December 7, 2023

Last Update Submit

April 16, 2026

Conditions

Breast Carcinoma

Keywords

MetastaticPET/CT 18F-FESCirculating markers

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

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

    54 months

Secondary Outcomes (10)

  • Progression-Free survival (PFS)

    54 months

  • Overall survival (OS)

    54 months

  • Objective response rate (ORR)

    54 months

  • Clinical benefit rate (CBR)

    24 weeks

  • Efficacy criteria: PFS at 24 weeks

    24 weeks

  • +5 more secondary outcomes

Study Arms (3)

Arm A: Endocrine therapy

SHAM COMPARATOR

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.

Combination Product: Endocrine therapyCombination Product: Endocrine therapy combined with the local treatment of FES-negative lesions

Arm B: Chemotherapy

ACTIVE COMPARATOR

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.

Combination Product: Endocrine therapyCombination Product: Chemotherapy

Arm C: Endocrine therapy

ACTIVE COMPARATOR

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.

Combination Product: Endocrine therapyCombination Product: Chemotherapy

Interventions

Endocrine therapyCOMBINATION_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.

Also known as: Standardized endocrine therapy regimen
Arm A: Endocrine therapyArm B: ChemotherapyArm C: Endocrine therapy
ChemotherapyCOMBINATION_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.

Also known as: Standardized chemotherapy regimen
Arm B: ChemotherapyArm C: Endocrine therapy
Endocrine therapy combined with the local treatment of FES-negative lesionsCOMBINATION_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.

Also known as: Standardized endocrine therapy regimen
Arm A: Endocrine therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Centre Hospitalier de la Côte basque

Bayonne, 64100, France

NOT YET RECRUITING

Institut Bergonié

Bordeaux, 33076, France

NOT YET RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

NOT YET RECRUITING

Centre Francois Baclesse

Caen, 14076, France

RECRUITING

Centre Georges Francois Leclerc

Dijon, 21079, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

CHU Limoges

Limoges, 87000, France

NOT YET RECRUITING

Centre Leon Bérard

Lyon, 69008, France

NOT YET RECRUITING

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Institut du Cancer Montpellier

Montpellier, 34298, France

RECRUITING

Centre Antoine lacassagne

Nice, 06189, France

RECRUITING

Hôpital Universitaire de Nimes

Nîmes, 30029, France

NOT YET RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Centre Eugène Marquis

Rennes, 35042, France

RECRUITING

Centre Henri Becquerel

Rouen, 76038, France

NOT YET RECRUITING

Institut Curie

Saint-Cloud, 92210, France

RECRUITING

Bruno MAUCHERAT

Saint-Herblain, 44805, France

WITHDRAWN

Centre de lutte contre le cancer Paul Strauss

Strasbourg, France

NOT YET RECRUITING

Oncopole Claudius Regaud

Toulouse, 31059, France

NOT YET RECRUITING

Hôpital Bretonneau-CHU Tours

Tours, 37044, France

NOT YET RECRUITING

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Steven Le GOUILL, PhD

    Institut Curie

    STUDY DIRECTOR

Central Study Contacts

François-Clément BIDARD, PhD

CONTACT

+33147111515francois-clement.bidard@curie.fr

Isabelle TURBIEZ

CONTACT

+33156245630drci.promotion@curie.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

January 8, 2024

Study Start

May 27, 2024

Primary Completion (Estimated)

September 27, 2029

Study Completion (Estimated)

September 27, 2030

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(21)