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

NCT02910219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-10-24

Study results available
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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.

Conditions

Interventions

DRUG

Crofelemer

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

Sponsors & Collaborators

  • Lombardi Comprehensive Cancer Center

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Napo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sandra Swain

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-11-23
Completion
2020-11-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02910219 on ClinicalTrials.gov