Recruiting

Tucatinib, Trastuzumab, Capecitabine

Sponsor:

Duke University

Code:

NCT06983691

Conditions

HER2+ Metastatic Breast Cancer (MBC)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient Navigation Program

Study Details

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.

Conditions

HER2+ Metastatic Breast Cancer (MBC)

Study ID

NCT06983691

Start date

Aug 11, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Patient Navigation Program

The patient navigation program will integrate 1) education to enhance understanding of the treatment regimen, follow-up care, and the importance of adherence, 2) symptom management and adherence strategies, and 3) skills and resources to enhance women's symptom coping and self-management abilities.

Interventions

Patient Navigation Program

The patient navigation program will integrate 1) education to enhance understanding of the treatment regimen, follow-up care, and the importance of adherence, 2) symptom management and adherence strategies, and 3) skills and resources to enhance women's symptom coping and self-management abilities.

Primary outcome measure

  • Number of participants enrolled [ Time Frame: 9 months ]
  • Percentage of participants completing 3 sessions [ Time Frame: 6 weeks ]
  • Percentage of participants using program strategies [ Time Frame: 6 weeks ]
  • Treatment Acceptability Questionnaire (TAQ) score [ Time Frame: 6 weeks ]
  • Client Satisfaction Questionnaire (CSQ) score [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Smrithi Divakaran, MPH

919-681-7695smrithi.divakaran@duke.edu

Michael W Willis

919-681-8437michael.w.willis@duke.edu

Locations

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michael W Willis, BA

919-681-8437michael.w.willis@duke.edu

Smrithi Divakaran, MPH

919-681-7695smrithi.divakaran@duke.edu

Principal Investigator:

Rebecca Shelby, PhD

More Information

Sponsor

Duke University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Patient Navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-08.