Informations générales (source: ClinicalTrials.gov)
ECLECTIC: EstroTEP and Circulating Biomarkers to Determine the Optimal Second Line Therapy for ER-positive HER2-negative Metastatic Breast Cancer Patients (ECLECTIC)
Interventional
Phase 3
Institut Curie (Voir sur ClinicalTrials)
mai 2024
septembre 2029
21 septembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:13 | Contacter | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/12/2024 12:44:01 | Contacter | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bruno MAUCHERAT - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Centre Antoine lacassagne - 06189 - Nice - France | Olivier Humbert, MD | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35042 - Rennes - France | Antoine DELEUZE, MD | Contact (sur clinicalTrials) | |||
| Centre Francois Baclesse - 14076 - Caen - France | George EMILE | Contact (sur clinicalTrials) | |||
| Centre Georges Francois Leclerc - 21079 - Dijon - France | Sylvain LADOIRE, MD | Contact (sur clinicalTrials) | |||
| Centre Leon Bérard - 69008 - Lyon - France | Elise ROWINSKI, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59000 - Lille - France | Nawale HAJJAJI, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Maxime Brunet, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Vincent Massard, MD | Contact (sur clinicalTrials) | |||
| Institut du Cancer Montpellier - 34298 - Montpellier - France | Marie ALEXANDRE, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13009 - Marseille - France | Alexandre TASSIN DE NONNEVILLE, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
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.
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.