Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Diarrhea
Intervention: Crofelemer
Intervention description: Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2; pertuzumab; trastuzumab; docetaxel; paclitaxel; carboplatin; crofelemer; chemotherapy induced diarrhea

Summary:

      Chemotherapy induced diarrhea is seen in up to 40-80% of patients receiving this treatment
      for HER2 positive locally advanced or metastatic breast cancer. This diarrhea can
      significantly impact a patient's quality of life and ability to tolerate chemo/anti-HER2
      therapy. This study will look at the efficacy of the drug crofelemer in preventing diarrhea
      in breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent;

          2. Men and women ≥18 years of age;

          3. Pathologically confirmed diagnosis of HER2 positive breast cancer of any stage
             (previous treatment is allowed without limits on lines of prior therapy);

          4. Scheduled to receive at least 3 consecutive cycles of THP or TCHP;

          5. Performance status of 0-2 according to the ECOG scale;

          6. Negative pregnancy test at time of informed consent for women of childbearing
             potential;

          7. Able to read, understand, follow the study procedure and complete crofelemer, rescue
             medication, and bowel movement diaries;

          8. Patients may enroll simultaneously on this study and other studies, including but not
             limited to NSABP B52;

          9. Patients with brain metastases (including concurrent steroid treatment) are allowed on
             this study.

         10. Left Ventricular Ejection Fraction (LVEF) greater or equal to 50% at baseline as
             determined by either ECHO or MUGA

        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.