Clinical trial · Observational
Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this non-interventional study (NIS) is to evaluate tucatinib (TUKYSA®) combined with trastuzumab and capecitabine in adult patients with locally advanced or metastatic HER2-positive breast cancer who have been previously treated with at least two anti-HER2 treatment regimens in a real-world setting,
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TUKYSA® | Drug | Tucatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 1st or 2nd palliative therapy line.
- interventionNames
- Drug: TUKYSA®
- label
- Cohort 2
- description
- Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 3rd or 4th palliative therapy line.
- interventionNames
- Drug: TUKYSA®
Primary outcomes (2)
- measure
- Time to deterioration of EORTC global health scale by at least 10 points
- timeFrame
- Baseline, up to 24 months
- description
- Only for prospectively enrolled patients: Time to deterioration of EORTC global health scale is defined as the time interval between fill-in date of baseline questionnaire and the first decrease in global health scale score ≥ 10-point (compared to baseline). If there was no such decrease, death will serve as event for this analysis, if occurring within 4 months after last filled-in questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available