Trial Title:
ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients
NCT ID:
NCT06195709
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Metastatic
PET/CT 18F-FES
Circulating markers
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Endocrine therapy
Description:
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.
Arm group label:
Arm A: Endocrine therapy
Arm group label:
Arm B: Chemotherapy
Arm group label:
Arm C: Endocrine therapy
Other name:
Standardized endocrine therapy regimen
Intervention type:
Combination Product
Intervention name:
Endocrine therapy combined with the local treatment of FES-negative lesions
Description:
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 group label:
Arm A: Endocrine therapy
Other name:
Standardized endocrine therapy regimen
Intervention type:
Combination Product
Intervention name:
Chemotherapy
Description:
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 group label:
Arm B: Chemotherapy
Arm group label:
Arm C: Endocrine therapy
Other name:
Standardized chemotherapy regimen
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Metastatic invasive breast carcinoma of no special type.
2. Females 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 antineoplastic therapy 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maxime Brunet, MD
Email:
m.brunet@bordeaux.unicancer.fr
Facility:
Name:
Centre Francois Baclesse
Address:
City:
Caen
Zip:
14076
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
George EMILE
Email:
g.emile@baclesse.unicancer.fr
Facility:
Name:
Centre Georges Francois Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sylvain LADOIRE, MD
Email:
sladoire@cgfl.fr
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nawale HAJJAJI, MD
Email:
n-hajjaji@o-lambret.fr
Facility:
Name:
Centre Leon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Elise ROWINSKI, MD
Email:
elise.rowinski@lyon.unicancer.fr
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Contact:
Last name:
Alexandre TASSIN DE NONNEVILLE, MD
Email:
tassindenonnevillea@ipc.unicancer.fr
Facility:
Name:
Institut du Cancer Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie ALEXANDRE, MD
Email:
Marie.Alexandre@icm.unicancer.fr
Facility:
Name:
Centre Antoine lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier Humbert, MD
Email:
Olivier.humbert@nice.unicancer.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Audrey BELLESOEUR, MD
Email:
audrey-bellesoeur@curie.fr
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35042
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Antoine DELEUZE, MD
Email:
a.deleuze@rennes.unicancer.fr
Facility:
Name:
Institut Curie
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Status:
Recruiting
Contact:
Last name:
François-Clément BIDARD, PhD
Email:
francois-clement.bidard@curie.fr
Facility:
Name:
Bruno MAUCHERAT
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Withdrawn
Facility:
Name:
Institut de Cancerologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54519
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Vincent Massard, MD
Email:
v.massard@nancy.unicancer.fr
Start date:
May 27, 2024
Completion date:
September 27, 2029
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Collaborator:
Agency:
Zionexa
Agency class:
Industry
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06195709
