Medical Imaging to Re-evaluate Elacestrant Clinical Usage
ConditionER+ / HER2- Advanced Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute
About this trial
The goal of this clinical trial is to evaluate whether elacestrant, an oral selective oestrogen receptor degrader, can improve outcomes in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer without detectable ESR1 mutation after progression on endocrine therapy plus a CDK4/6 inhibitor.
The study aims to answer two key questions:
* Does \[18F\]-fluor-oestradiol positron emission tomography/computed tomography (18F-FES-PET/CT) result (homogeneous vs. heterogeneous) determine the efficacy of elacestrant in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd? * Does 18F-FES-PET/CT imaging predict patient outcomes, including progression-free survival, overall survival, or tumor response?
There is no comparison group in this study. All participants receive elacestrant. Researchers will compare outcomes in people who have different levels of estrogen-receptor heterogeneity on FES-PET/CT imaging.
Participants in the study will:
* Take elacestrant 345 mg orally once a day, in 28-day treatment cycles (the dose may be lowered to 258 mg if needed due to side effects). * Undergo 18F-FES-PET/CT and 18F-FDG-PET/CT imaging both at the beginning of the study and as part of routine clinical evaluation every 8 weeks * Undergo blood sample collection every 8 weeks * If selected for a sub-study, undergo an additional FES-PET/CT scan 4 weeks after starting treatment
Eligibility criteria
Qualifiers
Age ≥ 18 years old
ECOG performance status ≤ 1
Must have histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease not amenable to therapy with curative intent or metastatic disease not amenable to curative therapy.
Documentation of ER-positive (≥10% positive stained cells) and HER2 negative (0-1+ by immunohistochemistry [IHC] or 2+ and negative by in situ hybridization [ISH] test) advanced or metastatic breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as per local assessment. ER-positive/HER2-negative status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease, where this might not possible.
Disqualifiers
Prior treatment with elacestrant, or an investigational SERD or ER antagonist.
Prior chemotherapy for advanced or metastatic disease.
a) Fulvestrant treatment (last injection) < 5 weeks before first dose of study drug.
b) Any other endocrine therapy < 14 days before first dose of study drug.
Trial design
Treatments tested in this trial
- Elacestrant
Treatment groups
160 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov