Nurse-led patient navigation for HER2+ metastatic breast cancer patients on tucatinib, trastuzumab, and capecitabine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial evaluates a nurse-led patient navigation program designed to support women with HER2+ metastatic breast cancer undergoing tucatinib-based therapy. Over about six weeks, participants receive navigation sessions and complete electronic assessments at baseline, around three weeks, and around six weeks, followed by an exit interview. The aim is to improve understanding of the treatment plan, manage symptoms and adherence, and boost coping and self-management skills. The study will determine the feasibility and acceptability of integrating patient navigation into routine care for this population. All activities occur at Duke Cancer Institute with collaboration from Pfizer.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke Cancer Institute
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Rebecca Shelby, PhD — Duke University
• Study coordinator: Smrithi Divakaran, MPH
• Email: smrithi.divakaran@duke.edu
• Phone: 919-681-7695

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tucatinib with trastuzumab and capecitabine for HER2‑positive metastatic breast cancer in routine care

  This project will see if tucatinib combined with trastuzumab and capecitabine works and is safe for people with HER2‑positive metastatic breast cancer who have had at least two prior anti‑HER2 treatments.

  Recruiting at 13 sites Fondazione Oncotech · Avellino, AV and 29 other locations · NCT07583485

• RO7771950 versus tucatinib with trastuzumab and capecitabine for HER2-positive locally advanced or metastatic breast cancer

  This test will see if RO7771950 combined with trastuzumab and capecitabine works better than tucatinib combined with the same drugs for people with HER2-positive locally advanced or metastatic breast cancer.

  Recruiting at 219 sites Phase 2/3 Hoffmann-La Roche · Huntsville, Alabama and 218 other locations · NCT07413939

• Tucatinib plus trastuzumab for HER3-mutant, HER2-not amplified metastatic breast cancer

  This trial will test whether combining tucatinib and trastuzumab helps people with metastatic or unresectable breast cancer whose tumors are HER2-negative but carry activating ERBB3 (HER3) mutations.

  Recruiting Phase 2 Institut Curie · Bordeaux and 8 other locations · NCT07193394

• Neoadjuvant treatment for HER2-positive breast cancer without chemotherapy

  This study is testing a new treatment using tucatinib, trastuzumab, and pertuzumab for people with stage II-III HER2-positive breast cancer to see if they can be treated without chemotherapy.

  Recruiting Phase 1 The Netherlands Cancer Institute · Amsterdam · NCT06162559

• Tucatinib combined with radiation for HER2-positive breast cancer with leptomeningeal disease

  This study is testing if combining radiation with a new treatment for HER2-positive breast cancer can help patients with brain involvement live longer and feel better.

  Recruiting at 2 sites Phase 2 Sunnybrook Health Sciences Centre · Ottawa, Ontario and 1 other locations · NCT06016387

• Combination treatment for metastatic HER2-positive breast cancer

  This study is testing a new combination of medications for people with HER2-positive metastatic breast cancer who haven't responded to previous treatments, to see if it can help them feel better and manage their disease.

  Recruiting at 9 sites Phase 2 Institut Curie · Clermont-Ferrand, Clermont Ferrand and 12 other locations · NCT05955170

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.