Evaluating tucatinib for advanced HER2-positive breast cancer after prior treatments

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

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.

Why it matters

Who can join: the full rules

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 it's running

• Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
  Essen, Northrhine-Westphalia, Germany Recruiting
• Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie
  Vienna, Austria Not yet recruiting

Study contacts

• Study coordinator: Cathrin Hogrefe, Dr.
• Email: Trace@iomedico.com
• Phone: +49761152420

Similar studies

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

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

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  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

• Can we skip radiation after lumpectomy for low-risk HER2-positive breast cancer?

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  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895511

• Breast cancer subtypes and outcomes in Colombian women

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  Recruiting Fundación Santa Fe de Bogota · Bogotá, Bogota D.C. · NCT07856225

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

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.