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Can a gut antibiotic ease Chemo's stomach woes?

NCT ID NCT04249622

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the antibiotic rifaximin (Xifaxan) to see if it could reduce stomach issues like bloating, pain, and diarrhea in people with early-stage HER2-positive breast cancer receiving pertuzumab-based chemotherapy. The trial planned to enroll 20 patients but was terminated early. The goal was to help patients complete their cancer treatment without delays or dose reductions due to side effects.

What this could mean

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

Active substance
rifaximin (Xifaxan)
What this could lead to
If it works, this could offer a way to manage severe stomach side effects from breast cancer treatment, helping patients stay on their chemotherapy schedule.
What could go wrong
This was a small, early-phase trial that was terminated before completion, so results are limited. It is not a treatment for cancer itself, only for side effects.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2022

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.

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: * PRE-REGISTRATION INCLUSION CRITERIA * Age \>= 18 years * Histological confirmation of HER2 positive breast cancer stage I-III per American Joint Committee on Cancer (AJCC) staging 8th edition * Provide written informed consent * Breast cancer patients who will be receiving pertuzumab-based chemotherapy with either TCHP (docetaxel, carboplatin, trastuzumab, and pertuzumab) or docetaxel/paclitaxel, trastuzumab, and pertuzumab * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Hemoglobin \>= 10.0 g/dL (obtained =\< 30 days prior to pre-registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 30 days prior to pre-registration) * Platelet count \>= 100 x 10\^9/L (obtained =\< 30 days prior to pre-registration) * Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 30 days prior to pre-registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN (obtained =\< 30 days prior to pre-registration) * Serum or plasma creatinine =\< 1.5 x ULN (obtained =\< 30 days prior to pre-registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to pre-registration) * Negative serum pregnancy test done =\< 30 days prior to pre-registration, for person of childbearing potential only * Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willingness to provide mandatory stool specimen for correlative research * Ability to complete questionnaire(s) by themselves or with assistance * REGISTRATION INCLUSION CRITERIA * Received pertuzumab based regimens in the adjuvant or neoadjuvant setting * Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 14 days prior to registration) * Platelet count \>= 100 x 10\^9/L (obtained =\< 14 days prior to registration) * Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 14 days prior to registration) * AST (SGOT)/ALT (SGPT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration) * Serum or plasma creatinine =\< 1.5 x ULN (obtained =\< 14 days prior to registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration) Exclusion Criteria: * PRE-REGISTRATION EXCLUSION CRITERIA * History of myocardial infarction =\< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment * EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment * Uncontrolled intercurrent non-cardiac illness including, but not limited to: * Ongoing or active infection * Psychiatric illness/social situations * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy * Any other conditions that would limit compliance with study requirements * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm (adjust to protocol if applicable) * Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception * Current colostomy or ileostomy * History of inflammatory bowel disease * History of irritable bowel syndrome * History of arteriovenous malformations * History of gastrointestinal bleeds * Previous surgical resection of the small bowel or colon * Previous allergy to rifaximin or its derivatives

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.