NCT06195709 ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients
| NCT ID | NCT06195709 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institut Curie |
| Condition | Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-05-27 |
| Primary Completion | 2029-09-27 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2024-05-27 with a primary completion date of 2029-09-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Metastatic invasive breast carcinoma of no special type. 2. Females and males 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 systemic treatment 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.
Contact & Investigator
Steven Le GOUILL, PhD
STUDY DIRECTOR
Institut Curie
Frequently Asked Questions
Who can join the NCT06195709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06195709 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06195709 currently recruiting?
Yes, NCT06195709 is actively recruiting participants. Contact the research team at francois-clement.bidard@curie.fr for enrollment information.
Where is the NCT06195709 trial being conducted?
This trial is being conducted at Bayonne, France, Bordeaux, France, Bordeaux, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT06195709 clinical trial?
NCT06195709 is sponsored by Institut Curie. The principal investigator is Steven Le GOUILL, PhD at Institut Curie. The trial plans to enroll 300 participants.