Estrogen Receptor Positive Breast CancerTn-MinerNCT06629233
Evaluation of a Novel Technique for the Discovery of New, Tumor-specific Targets for the Deployment of Innovative Immunotherapeutics Against Cancer.
A study testing Tumor resection in people with Estrogen Receptor Positive Breast Cancer, run by University Ghent at 2 sites in Belgium.
Trial summary
The goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor Positive Breast Cancer
- What is being tested?
- Tumor resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesBelgium
- Study dates
- 25 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Minimally 18 years old
- Diagnosed with estrogen-receptor positive breast cancer
- This must be a primary tumor
Who cannot join
- Male
- Younger than 18 years old
- Previous history of other tumors
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites
AZ Maria Middelares
Ghent, East-Flanders, 9000
University Hospital Ghent
Ghent, East-Flanders, 9000
About this study
Official title: Tn-Miner: Technology for the Discovery of Tumor-specific Glycopeptide Immunotherapy Targets.
The goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors.
The main goal it aims to achieve is:
Read more
To discover tumor-specific targets, that allow the use of very potent immunotherapeutic drugs as treatment for solid tumors, such as estrogen receptor positive breast cancer. These new targets are very specific for cancer cells, meaning that virtually no healthy cells should be attacked by the treatment, resulting in less side effects.
Participants will undergo standard of care treatment, comprising surgical removal of the breast tumor. Part of these tissues will be used for this clinical research.
- Conditions
- Estrogen Receptor Positive Breast Cancer
- Being tested
- Tumor resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor resectionProcedure or surgery
As the standard of care, estrogen receptor-positive breast tumors are surgically resected. From these resected tumors, small samples of both cancer tissue and healthy surrounding tissue will be analyzed using our patented Tn-Miner workflow to discover novel tumor-specific epitopes.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care tumor resection | Other | Not described Receives: Procedure: Tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovery of new, tumor-specific, glycopeptide epitopes.
The discovery of new antigens, comprising both glycan and peptide (=glycopeptide), on the outside of the plasma membrane of the breast cancer cells. These antigens should be absent on healthy cells. These new, glycopeptide antigens can be used as target for immunotherapeutics against cancer.
Measured: The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start25 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, Algemeen Ziekenhuis Maria Middelares
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629233
- Sponsor's protocol ID
- ONZ-2023-0589
- Other IDs
- F2022/IOF-StarTT/089
- Acronym
- Tn-Miner
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tn-Miner: Technology for the Discovery of Tumor-specific Glycopeptide Immunotherapy Targets.
- ClinicalTrials.gov ID
- NCT06629233
- Acronym / sponsor ID
- Tn-Miner / ONZ-2023-0589
- Conditions
- Estrogen Receptor Positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, Algemeen Ziekenhuis Maria Middelares
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (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.
The goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors.
The main goal it aims to achieve is:
To discover tumor-specific targets, that allow the use of very potent immunotherapeutic drugs as treatment for solid tumors, such as estrogen receptor positive breast cancer. These new targets are very specific for cancer cells, meaning that virtually no healthy cells should be attacked by the treatment, resulting in less side effects.
Participants will undergo standard of care treatment, comprising surgical removal of the breast tumor. Part of these tissues will be used for this clinical research.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care tumor resection | Other | Procedure: Tumor resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Minimally 18 years old
- Diagnosed with estrogen-receptor positive breast cancer
- This must be a primary tumor
Key exclusion criteria (3 listed)
- Male
- Younger than 18 years old
- Previous history of other tumors
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 |
|---|---|---|
| Tumor resectionAs the standard of care, estrogen receptor-positive breast tumors are surgically resected. From these resected tumors, small samples of both cancer tissue and healthy surrounding tissue will be analyzed using our patented Tn-Miner workflow to discover novel tumor-specific epitopes. | Procedure or surgery | Standard of care tumor resection |
Primary outcome
Discovery of new, tumor-specific, glycopeptide epitopes.
Time frame: The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.
The discovery of new antigens, comprising both glycan and peptide (=glycopeptide), on the outside of the plasma membrane of the breast cancer cells. These antigens should be absent on healthy cells. These new, glycopeptide antigens can be used as target for immunotherapeutics against cancer.
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 29 Aug 2025.
Related trials for Estrogen Receptor Positive 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
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
Not yet recruiting
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
Breast Cancer, Metastatic Breast Cancer
Recruiting
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Breast Neoplasms, Carcinoma, Ductal, Breast
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor resection in people with Estrogen Receptor Positive Breast Cancer, run by University Ghent at 2 sites in Belgium.
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 4 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: enrolling by invitation, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of new, tumor-specific, glycopeptide epitopes. (time frame: The patients are only involved during their standard of care surgery (one day). The discovered epitopes will not be shared with enrolled patients.). 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 29 Aug 2025.