Rifaximin for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Florida, Jacksonville, FLBreast Cancer+20 MoreRifaximin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • HER2-positive Breast Cancer
  • Stage IIB Breast Cancer
  • Stage III Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IA Breast Cancer
  • Stage 1 Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage 2 Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
CT-0508
1
Rifaximin
1
Ribociclib

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Year 3
Therapeutic procedure
Changes in the fecal microbiome, hydrogen breath test, and permeability test
Up to 3 years
Difference in the fecal microbiome, hydrogen breath test, and permeability test
Discontinuation of treatment with pertuzumab
Dose delays of treatment with pertuzumab
Dose reductions of treatment with pertuzumab
Other pertuzumab induced gastrointestinal toxicities (PIGT) such as abdominal pain, bloating and flatulence
Reduction rate of >= grade 2 abdominal toxicities including abdominal distension, abdominal pain, diarrhea, dyspepsia, stomach pain, and typhlitis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
CT-0508
1
Rifaximin
1
Ribociclib

Side Effects for

Rifaximin 550 mg BID
19%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%Headache
6%Dyspnoea
5%Renal failure acute
5%Anaemia
5%Vomiting
5%Asthenia
5%Anxiety
5%Cough
4%Diarrhoea
4%Jaundice
3%Cellulitis
3%Abdominal distension
3%Depression
2%Peritonitis bacterial
2%Bronchitis
2%Hyperkalaemia
2%Liver transplant
1%Septic shock
1%Non-cardiac chest pain
1%Sepsis
1%Pneumococcal bacteraemia
1%Pneumonia
1%Chest pain
1%Thrombocytopenia
1%Cardiac failure congestive
1%Gastrointestinal haemorrhage
1%Haematemesis
1%Haematochezia
1%Upper gastrointestinal haemorrhage
1%Systemic inflammatory response syndrome
1%Chronic hepatic failure
1%Hepatic failure
1%Hepatitis
1%Hepatorenal syndrome
1%Herpes zoster
1%Craniocerebral injury
1%Subdural haematoma
1%Dehydration
1%Fluid overload
1%Hyperglycaemia
1%Alcoholic seizure
1%Cerebrovascular accident
1%Subarachnoid haemorrhage
1%Toxic encephalopathy
1%Anxiety disorder
1%Suicidal ideation
1%Calculus ureteric
1%Oliguria
1%Renal failure
1%Acute respiratory failure
1%Pleural effusion
1%Hypovolaemic shock
1%Flatulence
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01842581) in the Rifaximin 550 mg BID ARM group. Side effects include: Hepatic encephalopathy with 19%, Oedema peripheral with 17%, Constipation with 16%, Nausea with 14%, Fatigue with 14%.

Trial Design

2 Treatment Groups

Arm II (pertuzumab-based chemotherapy)
1 of 2
Arm I (rifaximin, pertuzumab-based chemotherapy)
1 of 2

Active Control

Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: Rifaximin · No Placebo Group · Phase 2

Arm I (rifaximin, pertuzumab-based chemotherapy)Experimental Group · 3 Interventions: Best Practice, Rifaximin, Questionnaire Administration · Intervention Types: Other, Drug, Other
Arm II (pertuzumab-based chemotherapy)ActiveComparator Group · 2 Interventions: Best Practice, Questionnaire Administration · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,958 Previous Clinical Trials
3,449,433 Total Patients Enrolled
84 Trials studying Breast Cancer
17,027 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,156 Previous Clinical Trials
41,163,588 Total Patients Enrolled
928 Trials studying Breast Cancer
1,536,849 Patients Enrolled for Breast Cancer
Saranya ChumsriPrincipal InvestigatorMayo Clinic
8 Previous Clinical Trials
1,193 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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