NCT06983691 Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
| NCT ID | NCT06983691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | HER2+ Metastatic Breast Cancer (MBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2026-08-11 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2026-08-11 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * female (sex assigned at birth); * ≥18 years of age at enrollment; * diagnosed with HER2+ metastatic breast cancer (mBC); * receiving treatment with tucatinib combined with capecitabine and trastuzumab; * able to speak and read English Exclusion Criteria: * visual or hearing impairment; * severe cognitive impairment; * severe mental illness interfering with ability to participate
Contact & Investigator
Rebecca Shelby, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06983691 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HER2+ Metastatic Breast Cancer (MBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06983691 currently recruiting?
Yes, NCT06983691 is actively recruiting participants. Contact the research team at smrithi.divakaran@duke.edu for enrollment information.
Where is the NCT06983691 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06983691 clinical trial?
NCT06983691 is sponsored by Duke University. The principal investigator is Rebecca Shelby, PhD at Duke University. The trial plans to enroll 26 participants.
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