tucatinib in patients with locally advanced or metastatic her2-positive breast cancer who received at least two prior anti-her2 treatment regimens.

Conditions: HER2-positive Breast Cancer

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 breast cancer who have been previously treated with at least two anti-her2 treatment regimens in a real-world setting,

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 pivotal trial her2climb. in contrast to her2climb, trace will also include patients receiving tucatinib/trastuzumab/capecitabine during 1st and 2nd palliative therapy line who were primarily diagnosed with early breast cancer and therefore already have received two prior anti-her2 based treatment regimens before enrollment. until today, no reliable data is available for these patient population. trace will primarily focus on hrqol using the validated eortc qlq c30 + qlq-br23 + eq-5d-5l questionnaires. further aims are to evaluate effectiveness and safety in distinct subgroups focusing on effectiveness of tucatinib/trastuzumab/capecitabine in patients who have experienced prior therapies with trastuzumab and neratinib or capecitabine and her2-targeted tkis in the neoadjuvant, adjuvant or palliative setting, respectively. study sites may retrospectively include patients within 9 weeks (corresponds to 3 cycles) after start of study treatment up to 6 months after activation of respective site. retrospectively included patients may have already completed study treatment or may have already deceased at the time of inclusion.

Eligibility 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)

Keywords: her2-positive breast cancer tucatinib