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Study identifier: NCT07395336 Synced from ClinicalTrials.gov · July 29, 2026
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Elacestrant and Exemestane for Patients With Pretreated HR+/HER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE)

Condition: Breast Cancer  ·  Sponsor: European Institute of Oncology

PhasePhase 2
Planned participants26
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Single agent endocrine therapy (ET), with selective estrogen receptor degraders (SERDs; i.e. fulvestrant or elacestrant), is an option for patients with pre-treated hormone receptor-positive (HR+) breast cancer (BC) with indolent behaviour beyond the first line therapy with CDK4/6 inhibitors (CDK4/6i) + ET, in order to spare the adverse events related to chemotherapy. Anyway, the efficacy of endocrine monotherapy in patients progressing on first line therapy is low, because of the occurrence of endocrine resistance mechanisms, like the HR loss and the switch to HR-negative subtype, caused by the selective pressure of first line therapy; furthermore, biomarkers for patient selection are missing. Recently, the 16a-\[18F\]fluoro-17b-estradiol positron emission tomography (\[18F\]FES-PET) demonstrated a sensitivity and specificity of 86% in estrogen receptor expression prediction; therefore it is a promising tool to select patients progressing on CDK4/6i + ET without HR loss. Single agent endocrine therapy (ET), with selective estrogen receptor degraders (SERDs; i.e. fulvestrant or elacestrant), is an option for patients with pre-treated hormone receptor-positive (HR+) breast cancer (BC) with indolent behaviour beyond the first line therapy with target cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) + ET, in order to spare the adverse events related to chemotherapy. Anyway, the efficacy of endocrine monotherapy in patients progressing on first line therapy is low, becau…

This description comes directly from the study's public registry record.

Talk to the study team

Giuseppe Curigliano, MD  ·  0257489439  ·  giuseppe.curigliano@ieo.it

Carmine Valenza, MD  ·  carmine.valenza@ieo.it

Always discuss trial participation with your own doctor first.

Locations (1)

European Institute of OncologyMilan, Italy, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07395336