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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
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.
Institut Bergonié
Bordeaux, France
NOT_YET_RECRUITINGCentre Francois Baclesse
Caen, France
NOT_YET_RECRUITINGProgression-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
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
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
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
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
Efficacy criteria: PFS at 24 weeks
PFS at 24 weeks will be evaluated in patients allocated to arm A.
Time frame: 24 weeks
Efficacy criteria: OS at 24 weeks
OS at 24 weeks will be evaluated in patients allocated to arm A.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Centre Georges Francois Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
NOT_YET_RECRUITINGCentre Leon Bérard
Lyon, France
RECRUITINGInstitut Paoli-Calmettes
Marseille, France
RECRUITINGInstitut du Cancer Montpellier
Montpellier, France
RECRUITINGCentre Antoine lacassagne
Nice, France
NOT_YET_RECRUITINGInstitut Curie
Paris, France
RECRUITINGCentre Eugène Marquis
Rennes, France
NOT_YET_RECRUITING...and 3 more locations
Time frame: 24 weeks
Efficacy criteria: ORR at 24 weeks
ORR at 24 weeks will be evaluated in patients allocated to arm A.
Time frame: 24 weeks
Efficacy criteria: CBR at 24 weeks
CBR at 24 weeks will be evaluated in patients allocated to arm A.
Time frame: 24 weeks
Safety and toxicity and their relationship to study treatment
Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE v5.0
Time frame: 54 months
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.
Time frame: 2 months