Breast CancerPhase 2MELODYNCT07893730
Mapping the Enhanced Landscape of Advanced Breast Cancer fOr DYnamic Treatment Approaches
A Phase 2 study testing Liquid biopsy next generation sequencing in people with Breast Cancer and Metastatic Breast Cancer, run by University College Cork.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- What is being tested?
- Liquid biopsy next generation sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 31 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, male or female
- Locally advanced / inoperable or metastatic breast cancer suitable for systemic therapy, newly diagnosed or previously treated
- Histologically confirmed invasive breast cancer of any subtype
- No limitation on the number of prior lines of therapy
- ECOG Performance Status 0-3
- Capable of providing informed consent and willing to comply with study procedures
Who cannot join
- Patients who in opinion of supervising clinician are clinically too unwell to participate.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study intervention are not eligible for this trial.
- Pregnant or breastfeeding patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mapping the Enhanced Landscape of Advanced Breast Cancer fOr DYnamic Treatment Approaches (MELODY)
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.
- Being tested
- Liquid biopsy next generation sequencing
- Keywords
- liquid biopsy, circulating tumour DNA, precision oncology, metastatic breast cancer, microbiome, genomic profiling, next-generation sequencing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsy next generation sequencingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Liquid Biopsy Genomic Profiling | Experimental | 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. Receives: Diagnostic Test: Liquid biopsy next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Genomic Alterations
The number of genomic alterations detected
Measured: Baseline through to study completion, an average of 2 years
Relative proportion of genomic alterations
The relative proportion of genomic alterations
Measured: Baseline through to study completion, an average of 2 years
Secondary outcomes (7)
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
Measured: 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
Measured: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Actionability measured by treatment access via clinical trial
Measured: 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
Measured: 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
Measured: Baseline through to study completion, an average of 2 years
Overall survival
Time (in days) from enrolment to death from any cause
Measured: 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
Measured: Baseline through to study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital
- Responsible party
- Sponsor
- Investigators
- Roisin Connolly, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893730
- Sponsor's protocol ID
- 25156
- Acronym
- MELODY
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Enhanced Landscape of Advanced Breast Cancer fOr DYnamic Treatment Approaches (MELODY)
- ClinicalTrials.gov ID
- NCT07893730
- Acronym / sponsor ID
- MELODY / 25156
- Keywords
- liquid biopsy, circulating tumour DNA, precision oncology, metastatic breast cancer, microbiome, genomic profiling, next-generation sequencing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Cork University Hospital
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liquid Biopsy Genomic Profiling | Experimental | Diagnostic Test: Liquid biopsy next generation sequencingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older, male or female
- Locally advanced / inoperable or metastatic breast cancer suitable for systemic therapy, newly diagnosed or previously treated
- Histologically confirmed invasive breast cancer of any subtype
- No limitation on the number of prior lines of therapy
- ECOG Performance Status 0-3
Key exclusion criteria (3 listed)
- Patients who in opinion of supervising clinician are clinically too unwell to participate.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this study intervention are not eligible for this trial.
- Pregnant or breastfeeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid biopsy next generation sequencingBlood-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. | Diagnostic test | Liquid Biopsy Genomic Profiling |
Primary outcome
Frequency of Genomic Alterations
Time frame: Baseline through to study completion, an average of 2 years
The number of genomic alterations detected
Relative proportion of genomic alterations
Time frame: Baseline through to study completion, an average of 2 years
The relative proportion of genomic alterations
7 secondary outcomes
Concordance of tissue genomic profiling with plasma genomic profiling
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Time frame: Baseline through to study completion, an average of 2 years
Clinical Actionability of Detected Genomic Alterations
Time frame: Baseline through to study completion, an average of 2 years
Overall survival
Time frame: Measured at study completion; 2 years after enrolment
Time to Next Treatment
Time frame: Baseline through to study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roisin Connolly principal investigator
University College Cork
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liquid biopsy next generation sequencing in people with Breast Cancer and Metastatic Breast Cancer, run by University College Cork.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roisin Connolly (00353214903000, roisin.connolly@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Genomic Alterations (time frame: Baseline through to study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.