Clinical Trial

Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib

Not Yet Recruiting
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Summary
The goal of this study is to test a novel nurse-delivered patient navigation program for women with HER2+ metastatic breast cancer (mBC) receiving tucatinib, trastuzumab, and capecitabine. The program will focus on enhancing understanding of the treatment regimen, managing symptoms and adherence, and improving coping and self-management skills. If successful, the program could be integrated into clinical care to better support mBC patients. The main question the study aims to answer is: is the patient navigation program feasible and acceptable for mBC patients? Participants will receive patient navigation sessions over about 6 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3 and 6 weeks after enrollment, with the last assessment occurring after completion of the patient navigation program sessions. Participants will also complete a post-program exit interview.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-12 -> 2027-03 2026-07-09
minor Completion pushed: 2026-12 -> 2027-03 2026-07-09
Trial Details
NCT Number NCT06983691
Lead Sponsor Duke University
Collaborators: Pfizer
Conditions HER2+ Metastatic Breast Cancer (MBC)
Enrollment 26 participants
Start Date 2026-08
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-07