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