HER2+ Metastatic Breast Cancer (MBC) / Patient Navigation Program · Interventional Study

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

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered but not-yet-recruiting single-arm feasibility study of a nurse-delivered patient navigation program for HER2+ metastatic breast cancer patients receiving tucatinib-based therapy. The study will measure enrollment, session completion, strategy use, and acceptability over 6 weeks, with results not yet available in this registry record.

What was studied

Interventional, Single Group, Open label, Supportive Care purpose. HER2+ Metastatic Breast Cancer (MBC); Female; age from 18 Years. Intervention: Patient Navigation Program. n = 26.

Key findings

Safety

Outcomes are feasibility and acceptability measures, not clinical efficacy or safety endpoints.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned feasibility and acceptability study with no results posted; enrollment has not yet begun.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Number of participants enrolled (assessed at 9 months); Percentage of participants completing 3 sessions (assessed at 6 weeks); Percentage of participants using program strategies (assessed at 6 weeks); Treatment Acceptability Questionnaire (TAQ) score (assessed at 6 weeks); Client Satisfaction Questionnaire (CSQ) score (assessed at 6 weeks)

DesignInterventional, Single Group, Open label, Supportive Care purpose

PopulationHER2+ Metastatic Breast Cancer (MBC); Female; age from 18 Years

Sample size26

InterventionPatient Navigation Program

Reported figures

Quoted from the source exactly as published.

Planned enrollment26

Primary outcome: Number of participants enrolled9 months

Primary outcome: Percentage of participants completing 3 sessions6 weeks

Primary outcome: Percentage of participants using program strategies6 weeks

Primary outcome: Treatment Acceptability Questionnaire (TAQ) score6 weeks

Primary outcome: Client Satisfaction Questionnaire (CSQ) score6 weeks

Caveats

This is a registry record only; no results are reported or posted.
Single-arm design with no concurrent control or comparator group.
Recruitment has not yet begun (status: NOT_YET_RECRUITING).
Outcomes are feasibility and acceptability measures, not clinical efficacy or safety endpoints.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Single-arm interventional feasibility study with planned enrollment and structured assessments.

Directness

moderate

Addresses feasibility and acceptability in target population; outcomes are process-focused, not clinical.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or control arm.

Sample adequacy

limited

Planned enrollment 26 participants; small sample appropriate for feasibility study only.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06983691). This is a study registration, not published results. Lead sponsor: Duke University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 26 participants (ESTIMATED). Conditions: HER2+ Metastatic Breast Cancer (MBC). Interventions: BEHAVIORAL: Patient Navigation Program. Primary outcome measures: Number of participants enrolled , 9 months; Percentage of participants completing 3 sessions , 6 weeks; Percentage of participants using program strategies , 6 weeks; Treatment Acceptability Questionnaire (TAQ) score , 6 weeks; Client Satisfaction Questionnaire (CSQ) score , 6 weeks. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

HER2+ Metastatic Breast Cancer (MBC)NCT06983691Patient Navigation ProgramDuke University