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

ConditionBreast Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endocrine therapy

    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

    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.

  • Chemotherapy

    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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Arm A: Endocrine therapySham comparator 2 interventions
Group B: Arm B: ChemotherapyActive comparator 2 interventions
Group C: Arm C: Endocrine therapyActive comparator 2 interventions

Trial outcomes

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.

Time frame
54 months

Secondary outcomes

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.

Time frame
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)

Time frame
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,

Time frame
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.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Curie

Lead sponsor

Zionexa

Collaborator

Source ClinicalTrials.gov
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