Evaluating tucatinib for advanced HER2-positive breast cancer after prior treatments
Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens: a Multicenter, International, Prospective, Non-interventional Study in Germany and Austria (TRACE)
iOMEDICO AG · NCT05253911
This study is testing if a combination of tucatinib, trastuzumab, and capecitabine can help adults with advanced HER2-positive breast cancer feel better and improve their quality of life after they've already tried other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG (industry) |
| Drugs / interventions | trastuzumab, tucatinib, neratinib |
| Locations | 2 sites (Vienna and 1 other locations) |
| Trial ID | NCT05253911 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the effectiveness and safety of tucatinib combined with trastuzumab and capecitabine in adult patients with locally advanced or metastatic HER2-positive breast cancer who have previously undergone at least two anti-HER2 treatment regimens. Unlike previous trials, this study will include a broader patient population, including older individuals and those with more comorbidities. The study will focus on health-related quality of life and will utilize validated questionnaires to assess patient outcomes. It will also evaluate the treatment's effectiveness in various subgroups based on prior therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with histologically confirmed HER2-positive breast cancer who have received at least two prior anti-HER2 treatment regimens.
Not a fit: Patients who have not been treated with at least two prior anti-HER2 regimens or those with non-HER2-positive breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of tucatinib in a real-world setting, potentially improving treatment options for patients with advanced HER2-positive breast cancer.
How similar studies have performed: While this approach is based on existing treatments, it aims to fill a gap in real-world data for a specific patient population, making it a novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older. * Histologically confirmed HER2+ breast cancer with HER2 positivity defined as a 3+ score by immunohistochemistry (IHC) or a positive result by in situ hybridization (ISH), optionally combined with a IHC2+ score. * Diagnosis of locally advanced or metastatic HER2+ breast cancer, including patients with brain metastases. * Prior treatment with at least two prior anti-HER2-based regimens. * Decision for treatment with tucatinib in combination with trastuzumab and capecitabine according to current SmPC of tucatinib either in 1st/2nd palliative treatment line (Cohort 1) or 3rd/4th palliative treatment line (Cohort 2). * Progression after or intolerance of last systemic anti-HER2-based therapy. * Indication for treatment with tucatinib as assessed by the treating physician. * Signed written informed consent (only if patient is alive at time of inclusion, not applicable for retrospective inclusion of deceased patients). * Knowledge of German language. * Other criteria according to current SmPC of tucatinib Exclusion Criteria: * Contraindications according to SmPC of tucatinib * Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial. * Treatment with tucatinib/trastuzumab/capecitabine (=study treatment) in 5th or higher palliative therapy line. * Onset of tucatinib treatment later than 22 days after start of therapy line (in case tucatinib administration is started later than trastuzumab and/or capecitabine for any reason)
Where this trial is running
Vienna and 1 other locations
- Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie — Vienna, Austria (NOT_YET_RECRUITING)
- Universitätsklinikum Essen, Innere Klinik (Tumorforschung) — Essen, Northrhine-Westphalia, Germany (RECRUITING)
Study contacts
- Study coordinator: Cathrin Hogrefe, Dr.
- Email: Trace@iomedico.com
- Phone: +49761152420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HER2-positive Breast Cancer, HER2-positive breast cancer, Tucatinib