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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given standard of care pertuzumab-based chemotherapy
Ancillary studies
Given PO
Mayo Clinic in Florida
Jacksonville, Florida, United States
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).
Time frame: Through study completion (approximately 2 years, 3 months)
Dose Reductions of Treatment With Pertuzumab
Number of patients that experienced a dose reductions with pertuzumab due to gastrointestinal side effects.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Baseline (at enrollment); following each treatment cycle (21 days +/- 7 days), up to 5 cycles
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.