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Rifaximin for Breast Cancer-Related Gastrointestinal Side Effects
Phase 2
Waitlist Available
Led By Saranya Chumsri
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received pertuzumab based regimens in the adjuvant or neoadjuvant setting
Histological confirmation of HER2 positive breast cancer stage I-III per American Joint Committee on Cancer (AJCC) staging 8th edition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying if rifaximin can help reduce gastrointestinal side effects from pertuzumab-based therapy in patients with HER2 positive breast cancer.
Who is the study for?
This trial is for adults with stage I-III HER2 positive breast cancer who are receiving pertuzumab-based chemotherapy. They must have normal liver and kidney function, stable blood counts, and no history of significant gastrointestinal issues or recent heart attacks. Pregnant women, nursing mothers, those with certain illnesses or on antiretroviral therapy for HIV cannot participate.Check my eligibility
What is being tested?
The trial is testing if rifaximin can reduce gastrointestinal side effects caused by pertuzumab-based therapy in breast cancer patients without delaying their treatment schedule. Participants will also complete questionnaires to provide additional data.See study design
What are the potential side effects?
Rifaximin may cause mild digestive symptoms like bloating or gas. There's a low risk of allergic reactions in those sensitive to the medication. It's generally considered safe with a low profile of side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with pertuzumab for my cancer before surgery or as an initial treatment.
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My breast cancer is HER2 positive and is stage I-III.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I will be treated with a specific chemotherapy regimen for breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction rate of >= grade 2 abdominal toxicities including abdominal distension, abdominal pain, diarrhea, dyspepsia, stomach pain, and typhlitis
Secondary outcome measures
Therapeutic procedure
Discontinuation of treatment with pertuzumab
Dose delays of treatment with pertuzumab
+2 moreOther outcome measures
Changes in the fecal microbiome, hydrogen breath test, and permeability test - pertuzumab
Changes in the fecal microbiome, hydrogen breath test, and permeability test - rifaximin
Difference in the fecal microbiome, hydrogen breath test, and permeability test
Side effects data
From 2014 Phase 4 trial • 222 Patients • NCT0184258119%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Haematemesis
1%
Hyperglycaemia
1%
Acute respiratory failure
1%
Fluid overload
1%
Non-cardiac chest pain
1%
Gastrointestinal haemorrhage
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (rifaximin, pertuzumab-based chemotherapy)Experimental Treatment3 Interventions
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.
Group II: Arm II (pertuzumab-based chemotherapy)Active Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,063 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
Saranya ChumsriPrincipal InvestigatorMayo Clinic
8 Previous Clinical Trials
1,394 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidneys work well enough, with a specific level of creatinine clearance.I have been treated with pertuzumab for my cancer before surgery or as an initial treatment.You have had an allergic reaction to rifaximin or similar medicines in the past.I still have side effects from my last cancer treatment.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You are currently taking any other experimental medication for your main cancer.Women able to have children must have a negative pregnancy test done within the last 30 days before joining the study.Your blood test taken within the last 14 days shows you have enough infection-fighting white blood cells.I have had bleeding in my stomach or intestines before.Your liver function tests should not be more than 2.5 times the normal limit.My breast cancer is HER2 positive and is stage I-III.Your total bilirubin level should be within a certain range, which can be checked with a blood test.I have a history of abnormal connections between arteries and veins.My kidney function, measured by creatinine clearance, is good.Your platelet count is at least 100 billion per liter within the past two weeks.Your platelet count is at least 100 billion per liter of blood.Your kidney function test results should be within a certain range.Your hemoglobin level is at least 10.0 grams per deciliter, measured within the last 30 days before joining the study.I am 18 years old or older.I have had surgery to remove part of my small bowel or colon.You need to have a certain level of infection-fighting white blood cells in your body.Your hemoglobin level is at least 8.0 grams per deciliter, as tested within the last 14 days before joining the study.Your liver enzymes are not more than 2.5 times the normal level.Your total bilirubin level should be less than 1.5 times the normal limit.I have been diagnosed with irritable bowel syndrome.I am immunocompromised or HIV positive and on antiretroviral therapy.I have a history of inflammatory bowel disease.I can take care of myself and am up and about more than half of my waking hours.I am currently breastfeeding.I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.I am of childbearing age and do not plan to use birth control.I currently have a colostomy or ileostomy.Your kidney function test results should show that your creatinine level is not more than 1.5 times the upper limit of normal.I will be treated with a specific chemotherapy regimen for breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (rifaximin, pertuzumab-based chemotherapy)
- Group 2: Arm II (pertuzumab-based chemotherapy)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants enrolled in this experiment?
"Affirmative. According to clinicaltrials.gov, this trial is actively seeking participants. The project was introduced on September 18th 2020 and has since been edited as recently as September 8th 2022. A total of eighteen patients are needed from just one medical site."
Answered by AI
Is there currently room for enrolment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research endeavour is actively recruiting participants as of today's date. The study was first listed on September 18th 2020 with the latest update being published on September 8th 2022. A total of 18 candidates are needed from 1 location only."
Answered by AI
What potential risks do patients face when taking Rifaximin?
"Our team has cautiously rated Rifaximin's safety a 2, as this trial is still in its Phase 2 stages and only limited data exists on the drug's efficacy."
Answered by AI
Are there specific conditions for which Rifaximin is typically applied?
"Primarily utilized to combat recurrences of clostridium difficile infections, rifaximin has been known to effectively treat irritable bowel syndrome (IBS), bacterial infections, and cases of diarrhea."
Answered by AI
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