Predicting Endocrine Resistance Using Molecular Imaging and Liquid Biopsy in Metastatic Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
This prospective observational study aims to evaluate the prognostic value of molecular imaging biomarkers derived from baseline \[18F\]FES and \[18F\]FDG PET/CT for progression-free survival in patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer receiving first-line endocrine therapy combined with a CDK4/6 inhibitor. In a subset of patients with available tumor tissue, paired tumor tissue next-generation sequencing (NGS) and circulating tumor DNA (ctDNA) analysis will also be performed to investigate their associations with imaging biomarkers, treatment response, and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 19 years or older, regardless of race or ethnicity.
Histologically confirmed invasive breast cancer that is ER-positive and HER2-negative by immunohistochemistry.
Scheduled to initiate first-line systemic endocrine therapy with an aromatase inhibitor in combination with a CDK4/6 inhibitor for metastatic breast cancer within 60 days of screening.
Have undergone or be scheduled to undergo [18F]FDG PET/CT before initiation of endocrine therapy combined with a CDK4/6 inhibitor.
Disqualifiers
Failure of the participant or the participant's legally authorized representative to provide written informed consent.
History of another invasive malignancy within the previous 2 years, except for non-melanoma skin cancer.
Absence of lesions with significant uptake on [18F]FDG PET/CT, or inability to quantitatively evaluate major lesions because of lesion location (e.g., brain or other sites with high physiologic uptake), severe motion artifacts, reconstruction errors, or other technical limitations.
Metastatic disease confined exclusively to the liver on imaging.
Trial population
Patients with ER-positive, HER2-negative metastatic breast cancer who are scheduled to initiate first-line endocrine therapy with an aromatase inhibitor in combination with a CDK4/6 inhibitor at Asan Medical Center. Potentially eligible patients will be identified from the medical oncology outpatient clinic or inpatient wards and prospectively enrolled according to the predefined eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
[18F] FES
Diagnostic testParticipants will undergo baseline 18F-fluoroestradiol (\[18F\]FES) PET/CT before initiation of first-line endocrine therapy combined with a CDK4/6 inhibitor. \[18F\]FES (111-222 MBq) will be administered intravenously, and whole-body PET/CT imaging will be performed according to the institutional imaging protocol. \[18F\]FES PET/CT will be used to assess estrogen receptor expression and heterogeneity across metastatic lesions.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ER-Positive, HER2-Negative Metastatic Breast Cancer1 intervention
Trial outcomes
Primary outcomes
1
Prognostic value of baseline [18F]FES and [18F]FDG PET/CT-derived molecular imaging biomarkers for progression-free survival
Association of baseline molecular imaging biomarkers derived from \[18F\]FES and \[18F\]FDG PET/CT with progression-free survival (PFS) during first-line endocrine therapy combined with a CDK4/6 inhibitor
Time frame
From initiation of first-line endocrine therapy until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.Secondary outcomes
1
Prognostic value of baseline ctDNA-based liquid biopsy biomarkers for progression-free survival
Association of baseline ctDNA-based liquid biopsy biomarkers with progression-free survival during first-line endocrine therapy combined with a CDK4/6 inhibitor
Time frame
From initiation of first-line endocrine therapy until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.2
Prognostic value of baseline tumor tissue NGS findings for progression-free survival
Association of baseline tumor tissue NGS findings with progression-free survival during first-line endocrine therapy combined with a CDK4/6 inhibitor
Time frame
From initiation of first-line endocrine therapy until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.3
Prognostic value of changes in ctDNA-based liquid biopsy biomarkers at 12 weeks for progression-free survival
Association of changes in ctDNA-based liquid biopsy biomarkers from baseline to approximately 12 weeks after treatment initiation with progression-free survival during first-line endocrine therapy combined with a CDK4/6 inhibitor.
Time frame
From 12 weeks after treatment initiation until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months after treatment initiation.4
Association among baseline molecular imaging biomarkers, ctDNA-based liquid biopsy biomarkers, and tumor tissue NGS findings
Association among molecular imaging biomarkers derived from baseline \[18F\]FES and \[18F\]FDG PET/CT, baseline ctDNA-based liquid biopsy biomarkers, and tumor tissue NGS findings
Time frame
At baseline, before initiation of first-line endocrine therapy.Other outcomes
1
Prognostic value of changes in [18F]FDG PET/CT at 12 weeks for progression-free survival
Association of changes in \[18F\]FDG PET/CT findings at approximately 12 weeks after treatment initiation with progression-free survival during first-line endocrine therapy combined with a CDK4/6 inhibitor
Time frame
From 12 weeks after treatment initiation until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months after treatment initiation.2
Association between changes in [18F]FDG PET/CT and changes in ctDNA-based liquid biopsy biomarkers at 12 weeks
Association between changes in \[18F\]FDG PET/CT findings and changes in ctDNA-based liquid biopsy biomarkers from baseline to approximately 12 weeks after treatment initiation.
Time frame
From baseline to approximately 12 weeks after treatment initiation.3
Association among molecular imaging biomarkers, ctDNA-based liquid biopsy biomarkers, and tumor tissue NGS findings at disease progression
Association among molecular imaging biomarkers, ctDNA-based liquid biopsy biomarkers, and tumor tissue NGS findings assessed at the time of disease progression
Time frame
At the time of first documented disease progression, assessed up to 48 months after initiation of first-line endocrine therapy.4
Changes in molecular imaging biomarkers, ctDNA-based liquid biopsy biomarkers, and tumor tissue NGS findings from baseline to disease progression
Changes in molecular imaging biomarkers, ctDNA-based liquid biopsy biomarkers, and tumor tissue NGS findings between baseline and the time of disease progression
Time frame
From baseline to the time of first documented disease progression, assessed up to 48 months after initiation of first-line endocrine therapy.Sponsors and contacts
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Source ClinicalTrials.gov
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