CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Crofelemerdrug
Likely dose
Crofelemer 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02910219
NCT02910219Phase 2Completed
CompareCT.gov

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel With or Without Carboplatin: HALT-D

Sandra Swain·interventional·Posted Sep 21, 2016·Updated Oct 24, 2022

In Brief

A Phase 2 clinical trial evaluating Crofelemer for Breast Cancer. Completed, enrolled 53 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsLombardi Comprehensive Cancer Center, Medstar Health Research Institute, Genentech, Inc., Napo Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartJan 31, 2017
Primary CompletionNov 23, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.8 years ago

Interventions

Crofelemerdrug

Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP