Triple Negative Breast CancerMINANCT06709651
Microbiome Immunotherapy Neoadjuvant Assessment
An observational study of Triple Negative Breast Cancer, run by University College Cork at 1 site in Ireland.
Trial summary
Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 2 Oct 2024to Nov 2027
- Phase
- Observational
- 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
Study population: Patients in Cork University Hospital that meet inclusion criteria
Who may be able to join
- Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines.
- Be a male or female subject 18 years of age on day of signing informed consent.
- Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:
- HER2 negative in primary tumour pre-treatment by local pathology assessed according current ASCO/CAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.
- ER and PR negative in primary tumour pre-treatment defined as < 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
- Unresected, untreated breast cancer planned to undergo neoadjuvant systemic therapy, that meets one of the following clinical stages (see Appendix A):
- o T2, T3, or T4a-d lesion, any N, M0
- Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure).
Who cannot join
- Patients who are pregnant or breast-feeding
- Current use of any investigational agents
- History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Cork University Hospital
Cork, Munster
Roisin Connolly, 0214922687
About this study
Official title: Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer
Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with TNBC. It has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. Data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.
- Conditions
- Triple Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the breast cancer microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy
Microbiome evaluation with metagenomic sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and post-therapy timepoints)
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and pathologic complete response
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and pathologic complete response rate (pCR)
Measured: Through study completion, an average of 1 year
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and event-free survival
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and event free survival (EFS)
Measured: Through study completion, an average of 1 year
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and overall survival
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and overall survival (OS)
Measured: Through study completion, an average of 1 year
To determine the relationship between the breast cancer microbiome and tumor infiltrating leukocytes (TILs)
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and TILS (<50% versus ≥50%)
Measured: Through study completion, an average of 1 year
To determine the relationship between the breast cancer microbiome and programmed death ligand -1 (PDL-1)
Correlation between breast microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) and , PDL1 (positive defined as CPS ≥ 1 by PD-L1 IHC 22C3 assay versus negative)
Measured: Through study completion, an average of 1 year
To evaluate the gut microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy
Change in the gut microbiome composition (measured as percent abundance of microbial taxa derived from metagenomic sequencing) between pre- and post-therapy
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start2 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709651
- Sponsor's protocol ID
- 23120
- Acronym
- MINA
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2024
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Breast Microbiome and Tumor Microenvironment-related Biomarkers of Response to Neoadjuvant Systemic Therapy in Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06709651
- Acronym / sponsor ID
- MINA / 23120
- Conditions
- Triple Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Nov 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.
Predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage TNBC. Tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with TNBC. It has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. Data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Cork University Hospital that meet inclusion criteria
Key inclusion criteria (8 listed)
- Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines.
- Be a male or female subject 18 years of age on day of signing informed consent.
- Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:
- HER2 negative in primary tumour pre-treatment by local pathology assessed according current ASCO/CAP guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.
- ER and PR negative in primary tumour pre-treatment defined as < 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
Key exclusion criteria (3 listed)
- Patients who are pregnant or breast-feeding
- Current use of any investigational agents
- History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the breast cancer microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy
Time frame: Through study completion, an average of 1 year
Microbiome evaluation with metagenomic sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and post-therapy timepoints)
6 secondary outcomes
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and pathologic complete response
Time frame: Through study completion, an average of 1 year
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and event-free survival
Time frame: Through study completion, an average of 1 year
To examine the relationship between the local breast cancer microbiome in early-stage triple negative breast cancer and overall survival
Time frame: Through study completion, an average of 1 year
To determine the relationship between the breast cancer microbiome and tumor infiltrating leukocytes (TILs)
Time frame: Through study completion, an average of 1 year
To determine the relationship between the breast cancer microbiome and programmed death ligand -1 (PDL-1)
Time frame: Through study completion, an average of 1 year
To evaluate the gut microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy
Time frame: Through study completion, an average of 1 year
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 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by University College Cork at 1 site in Ireland.
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 8 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Contact Roisin Connolly (021 4922687, roisin.connolly@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the breast cancer microbiome pre- and post-therapy, in patients with early stage TNBC undergoing neoadjuvant systemic therapy (time frame: Through study completion, an average of 1 year). 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 4 Mar 2026.