Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT04249622
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
A Phase 2 study testing Best Practice, Questionnaire Administration and Rifaximin in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Best Practice, Questionnaire Administration and Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 27 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Phase II Trial of Rifaximin in Patients With Early Stage HER2 Positive Breast Cancer With Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the reduction rate of grade >= 2 abdominal toxicities, including abdominal distension, abdominal pain, diarrhea, dyspepsia, stomach pain, and typhlitis according to the National Cancer Institute Common Terminology for Adverse Events version 5.0 (NCI CTCAE v5.0) with the use of rifaximin in stage II-III HER-2 positive breast cancer patients with pertuzumab induced gastrointestinal toxicities.
SECONDARY OBJECTIVES:
- Evaluate dose reductions, dose delays and discontinuation of treatment with pertuzumab due to gastrointestinal side effects.
II. Evaluate and measure the change in the Bristol stool scale before and after rifaximin treatment.
III. Evaluate and measure the change in the 4-point Likert scale patient questionnaire before and after rifaximin treatment.
CORRELATIVE STUDY OBJECTIVES:
- Evaluate changes in the fecal microbiome, hydrogen breath test, and permeability test before and after rifaximin.
II. Evaluate changes in the fecal microbiome, hydrogen breath test, and permeability test before and after pertuzumab-based chemotherapy.
III. Evaluate the difference in the fecal microbiome, hydrogen breath test, and permeability test among patients with or without pertuzumab induced gastrointestinal toxicities (PIGT).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (GRADE >= 2 PIGT): Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin orally (PO) twice daily (BID) on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
ARM II (GRADE =< 1 PIGT): Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Best Practice, Questionnaire Administration, Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Given standard of care pertuzumab-based chemotherapy
Questionnaire AdministrationOther
Ancillary studies
RifaximinDrug
Also called Xifaxan
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (rifaximin, pertuzumab-based chemotherapy) | Experimental | Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Receives: Other: Best Practice; Other: Questionnaire Administration; Drug: Rifaximin |
| Arm II (pertuzumab-based chemotherapy) | Active comparator | Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Rate of >= Grade 2 Abdominal Toxicities Including Abdominal Distension, Abdominal Pain, Diarrhea, Dyspepsia, Stomach Pain, and Typhlitis
Based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).
Measured: Through study completion (approximately 2 years, 3 months)
Secondary outcomes (5)
Dose Reductions of Treatment With Pertuzumab
Number of patients that experienced a dose reductions with pertuzumab due to gastrointestinal side effects.
Measured: Up to 3 years
Dose Delays of Treatment With Pertuzumab
Number of patients that experienced a dose delay with pertuzumab due to gastrointestinal side effects.
Measured: Up to 3 years
Discontinuation of Treatment With Pertuzumab
The number of patients that experienced discontinuation of treatment with pertuzumab due to gastrointestinal side effects.
Measured: Up to 3 years
Number of Patient With a Reduction of Mean Number of Stools
Number of patients that experienced a reduction of mean number of stools recorded while on treatment compared to baseline will be reported
Measured: Up to 3 years
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Maximum PIGT score represents the maximum grade of adverse event experienced by a patient out of all gastrointestinal adverse events. PIGT scores are assessed according to NCI CTCAE v5.0, with a minimum grade of 0 (no event) and maximum grade of 5 (death).
Measured: Baseline (at enrollment); following each treatment cycle (21 days +/- 7 days), up to 5 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start18 Sep 2020
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saranya Chumsri, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249622
- Sponsor's protocol ID
- MC18C3
- Other IDs
- NCI-2020-00332, MC18C3, 18-009108
- Status last verified
- Aug 2025
- First submitted
- 27 Jan 2020
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Rifaximin in Patients With Early Stage HER2 Positive Breast Cancer With Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy
- ClinicalTrials.gov ID
- NCT04249622
- Acronym / sponsor ID
- MC18C3
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the reduction rate of grade >= 2 abdominal toxicities, including abdominal distension, abdominal pain, diarrhea, dyspepsia, stomach pain, and typhlitis according to the National Cancer Institute Common Terminology for Adverse Events version 5.0 (NCI CTCAE v5.0) with the use of rifaximin in stage II-III HER-2 positive breast cancer patients with pertuzumab induced gastrointestinal toxicities.
SECONDARY OBJECTIVES:
- Evaluate dose reductions, dose delays and discontinuation of treatment with pertuzumab due to gastrointestinal side effects.
II. Evaluate and measure the change in the Bristol stool scale before and after rifaximin treatment.
III. Evaluate and measure the change in the 4-point Likert scale patient questionnaire before and after rifaximin treatment.
CORRELATIVE STUDY OBJECTIVES:
- Evaluate changes in the fecal microbiome, hydrogen breath test, and permeability test before and after rifaximin.
II. Evaluate changes in the fecal microbiome, hydrogen breath test, and permeability test before and after pertuzumab-based chemotherapy.
III. Evaluate the difference in the fecal microbiome, hydrogen breath test, and permeability test among patients with or without pertuzumab induced gastrointestinal toxicities (PIGT).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (GRADE >= 2 PIGT): Patients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin orally (PO) twice daily (BID) on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
ARM II (GRADE =< 1 PIGT): Patients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (rifaximin, pertuzumab-based chemotherapy) | Experimental | Other: Best Practice, Other: Questionnaire Administration, Drug: RifaximinPatients that experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy receive rifaximin PO BID on days 1-5 and standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. |
| Arm II (pertuzumab-based chemotherapy) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients that do not experience PIGT after receiving first standard of care cycle of pertuzumab-based chemotherapy continue receiving standard of care pertuzumab-based chemotherapy on day 1. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (23 listed)
- 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
- Uncontrolled intercurrent non-cardiac illness including, but not limited to:
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyGiven standard of care pertuzumab-based chemotherapy | Other | Arm I (rifaximin, pertuzumab-based chemotherapy), Arm II (pertuzumab-based chemotherapy) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (rifaximin, pertuzumab-based chemotherapy), Arm II (pertuzumab-based chemotherapy) |
| RifaximinAlso: XifaxanGiven PO | Drug | Arm I (rifaximin, pertuzumab-based chemotherapy) |
Primary outcome
Reduction Rate of >= Grade 2 Abdominal Toxicities Including Abdominal Distension, Abdominal Pain, Diarrhea, Dyspepsia, Stomach Pain, and Typhlitis
Time frame: Through study completion (approximately 2 years, 3 months)
Based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner (1987).
5 secondary outcomes
Dose Reductions of Treatment With Pertuzumab
Time frame: Up to 3 years
Dose Delays of Treatment With Pertuzumab
Time frame: Up to 3 years
Discontinuation of Treatment With Pertuzumab
Time frame: Up to 3 years
Number of Patient With a Reduction of Mean Number of Stools
Time frame: Up to 3 years
Average Maximum Pertuzumab Induced Gastrointestinal Toxicities (PIGT) Score
Time frame: Baseline (at enrollment); following each treatment cycle (21 days +/- 7 days), up to 5 cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Saranya Chumsri, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Questionnaire Administration and Rifaximin in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
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 26 inclusion and 23 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: stopped early, as of the sponsor's last update on 16 Sep 2025. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction Rate of >= Grade 2 Abdominal Toxicities Including Abdominal Distension, Abdominal Pain, Diarrhea, Dyspepsia, Stomach Pain, and Typhlitis (time frame: Through study completion (approximately 2 years, 3 months)). 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 16 Sep 2025.