Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

Exclusion Criteria

• •1. Pregnant and/or breastfeeding;
• •2. Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn's disease, microscopic colitis, etc.);
• •3. Use of investigational drugs within 3 weeks of signing consent or foreseen use during the study;
• •4. Use of chemotherapy, trastuzumab, or pertuzumab within the past 3 weeks;
• •5. Use of antibiotics within the past 7 days (up to 2 prophylactic doses of antibiotics for procedures including, but not limited to port placement, is permitted);
• •6. Any type of ostomy;
• •7. Total colectomy;
• •8. Fecal incontinence;
• •9. Ongoing radiation induced diarrhea or constipation or planned radiotherapy to the abdomen or pelvis while on study;
• •10. Active systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasites, anti-virals;
• •11. Abdominal or pelvic surgery without recovery of bowel function;
• •12. Inadequate organ function for starting THP or TCHP, which may include the following laboratory results within 28 days prior to signing consent:
• •1. Total bilirubin \> upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)
• •2. Serum creatinine \> 2.0 mg/dL or 177 μmol/L
• •3. AST (SGOT) and ALT (SPGT) \> 2.5 ULN.