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

• Status: Completed
• Trial end date: 2020-11-23
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Georgetown University
• Collaborators: Genentech, Inc.; Lombardi Comprehensive Cancer Center; Medstar Health Research Institute; Napo Pharmaceuticals, Inc.
• Treatments: Carboplatin; Docetaxel; Paclitaxel; Pertuzumab; Trastuzumab

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.