Trials / Terminated

TerminatedNCT04249622

Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer

Phase II Trial of Rifaximin in Patients With Early Stage HER2 Positive Breast Cancer With Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 20 (actual)

Sponsor: Mayo Clinic · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.

Detailed description

PRIMARY OBJECTIVE: I. 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: I. 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: I. 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

Interventions

Type	Name	Description
OTHER	Best Practice	Given standard of care pertuzumab-based chemotherapy
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Rifaximin	Given PO

Timeline

Start date: 2020-09-18
Primary completion: 2022-12-27
Completion: 2022-12-27
First posted: 2020-01-31
Last updated: 2025-09-16
Results posted: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04249622. Inclusion in this directory is not an endorsement.