HER2+ Metastatic Breast Cancer (MBC)NCT06983691
Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
A study testing Patient Navigation Program in people with HER2+ Metastatic Breast Cancer (MBC), run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2+ Metastatic Breast Cancer (MBC)
- What is being tested?
- Patient Navigation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- visual or hearing impairment;
- severe cognitive impairment;
- severe mental illness interfering with ability to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Michael W Willis, BA, 919-681-8437, michael.w.willis@duke.edu
Smrithi Divakaran, MPH, 919-681-7695, smrithi.divakaran@duke.edu
About this study
Official title: Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
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)
- Being tested
- Patient Navigation Program
- Keywords
- Patient Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation Program | Experimental | 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. Receives: Behavioral: Patient Navigation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled
Feasibility will be assessed by examining pilot study enrollment.
Measured: 9 months
Percentage of participants completing 3 sessions
Feasibility will be assessed by examining retention (>80% completing 3 sessions).
Measured: 6 weeks
Percentage of participants using program strategies
Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies).
Measured: 6 weeks
Treatment Acceptability Questionnaire (TAQ) score
Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The program will be considered acceptable if >80% of participants rate the program as >5 out of 7 on the TAQ. A higher score indicates greater acceptability.
Measured: 6 weeks
Client Satisfaction Questionnaire (CSQ) score
Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The program will be considered acceptable if >80% of participants rate the program as >3 out of 4 on the CSQ. A higher score indicates greater acceptability.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start11 Aug 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2+ Metastatic Breast Cancer (MBC)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983691
- Sponsor's protocol ID
- Pro00117920
- Status last verified
- Sep 2026
- First submitted
- 14 May 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
- ClinicalTrials.gov ID
- NCT06983691
- Acronym / sponsor ID
- Pro00117920
- Conditions
- HER2+ Metastatic Breast Cancer (MBC)
- Keywords
- Patient Navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation Program | Experimental | Behavioral: Patient Navigation ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- visual or hearing impairment;
- severe cognitive impairment;
- severe mental illness interfering with ability to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigation ProgramThe 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. | Behavioural | Patient Navigation Program |
Primary outcome
Number of participants enrolled
Time frame: 9 months
Feasibility will be assessed by examining pilot study enrollment.
Percentage of participants completing 3 sessions
Time frame: 6 weeks
Feasibility will be assessed by examining retention (>80% completing 3 sessions).
Percentage of participants using program strategies
Time frame: 6 weeks
Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies).
Treatment Acceptability Questionnaire (TAQ) score
Time frame: 6 weeks
Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The program will be considered acceptable if >80% of participants rate the program as >5 out of 7 on the TAQ. A higher score indicates greater acceptability.
Client Satisfaction Questionnaire (CSQ) score
Time frame: 6 weeks
Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The program will be considered acceptable if >80% of participants rate the program as >3 out of 4 on the CSQ. A higher score indicates greater acceptability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for HER2+ Metastatic Breast Cancer (MBC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation Program in people with HER2+ Metastatic Breast Cancer (MBC), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smrithi Divakaran, MPH (919-681-7695, smrithi.divakaran@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.