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Gut bacteria linked to chemo success in aggressive breast cancer

NCT ID NCT03586297

Knowledge-focused Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether the types of bacteria in the gut and inside tumors affect how well chemotherapy works in triple negative breast cancer. Researchers followed 49 patients receiving standard chemotherapy before surgery. They collected samples to see if certain bacteria were linked to a complete response, where no cancer remains after treatment.

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 help doctors predict which patients will respond best to chemotherapy based on their gut bacteria.
What could go wrong
This is a small, completed observational study. It does not test a new treatment, so results may not lead to immediate changes in care.

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

49 people

The number who actually took part.

Started

Aug 2017

Finished

Sep 2025

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

Newly Diagnosed Triple Negative Breast Cancer Patients

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: * Histologically confirmed new diagnosis of TNBC (\<5% of ER and PR immunoreactivity and HER2- by FISH or IHC staining 0 or 1+) * \>18 years * 1.5 cm mass lesion or greater * Tumor amenable to percutaneous core biopsy Exclusion Criteria: * chronic anticoagulation therapy * prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy * Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection * lactating * pregnant

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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

Contacts and locations

Locations

  • Georgetown University

    Washington D.C., District of Columbia, 20057, United States

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601, United States

  • Yale University - Yale Cancer Center

    New Haven, Connecticut, 06520-8327, United States

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