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

StatusRecruiting
PhaseNot applicable
Started2026-08-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 2026 → Mar 2027
See other at-risk trials from Duke University

Amendment history

2026-09-02
notable
Study Status, Contacts/Locations v4
Recruitment opened
Start dateestimated 2026-08→confirmed 2026-08-11
Study sites0→1
2026-08-05
minor
Study Status, Study Description, Outcome Measures v3
Start date2026-07→2026-08
2026-07-07
notable
Study Status v2
Primary completion pushed: 2026-12 → 2027-03
Completion pushed: 2026-12 → 2027-03
Start date2026-04→2026-07
2026-03-04
minor
Study Status v1
Primary completion date2026-10→2026-12
Completion date2026-10→2026-12
Start date2026-01→2026-04
2025-05-14
minor
Original filing
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.
Trial Details
NCT Number NCT06983691
Lead Sponsor Duke University
Collaborators: Pfizer
Conditions HER2+ Metastatic Breast Cancer (MBC)
Enrollment 26 participants
Start Date 2026-08-11
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-08