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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Elacestrant
DrugElacestrant is an orally available tetrahydronaphthalene compound that acts as selective oestrogen receptor alpha (ERα) antagonist with receptor degrading activity (e.g., selective oestrogen receptor degrader, SERD) and is being developed as a monotherapy agent and in combinations for the treatment of oestrogen receptor (ER) positive breast cancer.
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Elacestrant Treatment for ER-Positive, HER2-Negative Breast Cancer Without ESR1 MutationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival in participants with ESR1-mut-nd
To determine the efficacy of elacestrant by 18F-FES-PET/CT result (homogeneous vs. heterogeneous) in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd.
Time frame
From first day of treatment until 6 months after first day of treatmentSecondary outcomes
1
Progression-Free Survival (PFS) by central review as per (Response Evaluation Criteria In Solid Tumors) RECIST v1.143/ PET Response Criteria In Solid Tumours (PERCIST)
To determine the efficacy of elacestrant, PFS, by central review as per RECIST v1.143/ PERCIST39,44 by 18F-FES-PET/CT result.
Time frame
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)2
Objective Response Rate (ORR) by central review, defined as per RECIST v1.143/ PERCIST
To evaluate the efficacy of elacestrant, by objective response rate (ORR), in the full analysis set and by 18F-FES-PET/CT result.
Time frame
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)3
Overall Survival (OS), defined as time from the date of treatment start to the date of death from any cause.
To evaluate the efficacy of elacestrant, by OS, in the full analysis set and by 18F-FES PET/CT result.
Time frame
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)4
PFS and OS rates at 6-month and at 12-month
To determine the efficacy of elacestrant by PFS and OS at landmark timepoints of 6stuyd-month and 12-month rate.
Time frame
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)Other outcomes
1
Exploratory objective: PFS in participants treated with elacestrant according to predefined 18F-FES-PET/CT heterogeneity threshold categories.
To assess PFS across predefined strata of 18F-FES-PET/CT heterogeneity threshold.
Time frame
From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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