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
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
Treatments tested in this trial
- Endocrine therapy
- Endocrine therapy combined with the local treatment of FES-negative lesions
- Chemotherapy
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Institut Curie
Lead sponsor
Zionexa
Collaborator
Source ClinicalTrials.gov