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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pertuzumab; Rifaximin

Criteria

Inclusion Criteria:

• 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

• 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)

Exclusion Criteria:

• 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

• 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