A Phase 2 interventional study of Liquid biopsy next generation sequencing in Breast Cancer, Metastatic Breast Cancer and Locally Advanced Breast Cancer (LABC), sponsored by University College Cork. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University College Cork · Phase 2, Interventional, and Diagnostic
MELODY is a prospective, single-arm phase II study introducing routine liquid-biopsy next-generation sequencing for patients with advanced or unresectable breast cancer in Ireland. The study will characterise genomic alterations detected in plasma and tumour tissue, assess concordance and clinical actionability, and evaluate clinical, operational, economic, patient-reported and exploratory translational outcomes.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants with advanced or unresectable breast cancer undergo serial sampling by plasma next-generation sequencing with comparison to tumour-tissue genomic profiling, clinical follow-up and patient-reported assessments.
Diagnostic Test: Liquid biopsy next generation sequencing
Blood-based genomic profiling of circulating tumour nucleic acids, performed at baseline and serially, to identify genomic alterations and inform comparison with tumour-tissue sequencing and potential treatment actionability.
Frequency of Genomic Alterations
The number of genomic alterations detected
Time frame: Baseline through to study completion, an average of 2 years
Relative proportion of genomic alterations
The relative proportion of genomic alterations
Time frame: Baseline through to study completion, an average of 2 years
Concordance of tissue genomic profiling with plasma genomic profiling
To assess the concordance of liquid biopsy plasma genomic profiling compared to tumour-tissue genomic profiling
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Actionability classified using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT); classified either Tier I, II, III, IV, V or X
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Actionability measured by treatment access via clinical trial
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Actionability measured by treatment access via expanded access programme eligibility
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Actionability measured by treatment access via standard of care
Time frame: Baseline through to study completion, an average of 2 years
Overall survival
Time (in days) from enrolment to death from any cause
Time frame: Measured at study completion; 2 years after enrolment
Time to Next Treatment
Time (in days) from enrolment to commencement of the next line of treatment
Time frame: Baseline through to study completion, an average of 2 years
Genomic Profiling Turnaround Time
Time in days from ordering plasma genotyping to reporting results, and comparison with tissue-genotyping turnaround time where paired results are available
Time frame: At each liquid biopsy sample collection
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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