Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients (NCT02910219) | Clinical Trial Compass
CompletedPhase 2
Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients
United States53 participantsStarted 2017-01-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diarrhea for >= 2 Consecutive Days
Timeframe: Cycle 1, Cycle 2 (each cycle is 21 days)
. Patients may enroll simultaneously on this study and other studies, including but not limited to NSABP B52;
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);