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Could bacteria in breast tumors predict who responds to cancer therapy?

NCT ID NCT06709651

Knowledge-focused Sponsor: University College Cork Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at bacteria living in breast tumors of people with triple negative breast cancer. Researchers want to see if these bacteria can help predict who will respond well to chemotherapy and immunotherapy before surgery. The study will collect tumor samples before and after treatment from 30 participants to analyze changes in the microbiome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a new way to predict which patients will respond to chemotherapy and immunotherapy, helping tailor treatment for triple negative breast cancer.
What could go wrong
This is a small, early-stage observational study with only 30 participants. It is not testing a treatment, so it may not directly change patient care. The findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients in Cork University Hospital that meet inclusion criteria

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial in accordance with national/local guidelines. 2. Be a male or female subject 18 years of age on day of signing informed consent. 3. 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. 4. 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 5. Be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure). Exclusion Criteria: 1. Patients who are pregnant or breast-feeding 2. Current use of any investigational agents 3. 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.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cork University Hospital

    RECRUITING

    Cork, Munster, Ireland

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