Status:
COMPLETED
Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.
Lead Sponsor:
iOMEDICO AG
Collaborating Sponsors:
Seagen Germany GmbH (a Pfizer company)
Conditions:
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 b...
Detailed Description
TRACE will collect real-world data on the treatment of tucatinib/trastuzumab/capecitabine in a broad patient population including older patients and patients with more comorbidities as compared to the...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05253911
Start Date
May 21 2022
End Date
June 30 2025
Last Update
December 4 2025
Active Locations (2)
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1
Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie
Vienna, Austria, 1090
2
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen, North Rhine-Westphalia, Germany, D-45112