Phase 2 N=53 Randomized Prevention

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02910219 ↗

Enrolled (actual)

Serious AEs

15.7%

Results posted

Oct 2022

Primary outcome: Primary: Diarrhea for >= 2 Consecutive Days — 68; 69.6; 65.2; 72.2 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Crofelemer (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sandra Swain
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Diarrhea for >= 2 Consecutive Days	68; 69.6; 65.2; 72.2	—
SECONDARY Diarrhea Any Grade	16; 16; 15; 18	—
SECONDARY Grade 3-4 Diarrhea	1; 2; 0; 4	—
SECONDARY Diarrhea Onset	3; 2	—
SECONDARY Diarrhea Duration	13; 15; 15; 12	—
SECONDARY Duration Grade 3-4 Diarrhea	18; 6.5	—
SECONDARY Anti-diarrheal Medications	20.69; 24.73; 16.25; 21.24; 16.15; 2.272	—
SECONDARY FACIT-D Total Score	129.0; 123.8; 116.7; 114.4	—
SECONDARY FACIT-D Diarrhea Score	40.5; 39.8; 34.9; 34.1	—
SECONDARY Stool Frequency Based on Consistency (Bristol Stool Scale)	14.5; 19; 14.0; 17.5	—

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

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02910219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.