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Bacteria inside tumors may hold the key to breast cancer treatment

NCT ID NCT07808086

Knowledge-focused Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study looks at how bacteria inside tumors and the immune cells around them affect how well triple-negative breast cancer responds to chemotherapy and immunotherapy. Researchers will collect tumor, blood, and stool samples from 30 women before and during treatment. They want to see if these factors can predict which patients benefit most, which could lead to more personalized care.

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 research could identify biomarkers that help doctors predict which patients with triple-negative breast cancer will benefit most from chemotherapy and immunotherapy, leading to more personalized treatment plans.
What could go wrong
This is an early, observational study with only 30 participants. The findings may not apply to all patients, and the identified biomarkers may not prove reliable in larger, more diverse groups.

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

Sep 2026

Expected to finish

Aug 2029

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

The study population will include patients referred to the Breast Unit of IRCCS ICS Maugeri of Pavia and the Istituto Nazionale dei Tumori of Milan, diagnosed with triple-negative breast cancer and scheduled for neoadjuvant treatment followed by surgery.

Ages

18 years and older

Sex

Female participants only

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: * Female subjects * Diagnosis of triple-negative breast cancer (TNBC) * Aged 18 years or older * Indication for neoadjuvant treatment with chemotherapy or chemo/immunotherapy. * Patients willing and able to comply to standard oncological follow-up procedures. * Subjects who agree to participate in the present study by signing and dating the informed consent form. Exclusion Criteria: If a subject meets any of the following criteria, they must be excluded from the study. * Patients that have already been treated with chemotherapy. * Patients that did not receive an official cyto-histological diagnosis of breast cancer. * Patients affected by other solid tumors other than breast cancer. * Patients who have undergone antibiotic therapy within the 10 days prior to sample collection.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

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

  • Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCS

    RECRUITING

    Pavia, 27100, Italy

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