An observational study in HER2-positive Breast Cancer, sponsored by iOMEDICO AG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by iOMEDICO AG · Observational
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.
iOMEDICO AG is the lead sponsor of 52 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been previously treated with at least two prior anti-HER2 treatment regimens and with decision for treatment with tucatinib (TUKYSA®) in combination with trastuzumab and capecitabine.
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).
Exclusion Criteria:
Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 1st or 2nd palliative therapy line.
Drug: TUKYSA®
Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 3rd or 4th palliative therapy line.
Drug: TUKYSA®
tucatinib/trastuzumab/capecitabine according to TUKYSA® SmPC.
Time to deterioration of EORTC global health scale by at least 10 points
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.
Time frame: Baseline, up to 24 months
Changes in the global health scale
Only for prospectively enrolled patients: Changes in global health is provided by descriptive statistics of the EQ-5D-5L index value, the EQ-5D-5L visual analogue scale, the EORTC QLQ-C30 global health scale and all functional and symptom scores of the EORTC questionnaires.
Time frame: Baseline, up to 24 months
Time to next systemic treatment (TTNT)
TTNT (time to next systemic treatment) is defined as time from first administration of any study treatment (i.e., tucatinib/trastuzumab/capecitabine treatment) to start of a subsequent systemic antineoplastic therapy or death, whichever comes first.
Time frame: Baseline, up to 5 years
Time to local intracranial treatment (TLT)
TLT (time to local intracranial treatment) is defined as time from first administration of any study treatment to start of a local intracranial therapy, end of a treatment interruption due to isolated intracranial progression, change of treatment strategy or death, whichever comes first. It will be analyzed for patients with isolated intracranial progression after start of study treatment.
Time frame: Baseline, up to 5 years
Overall response rate (ORR)
ORR is defined as proportion of patients with any response (partial or complete remission) overall.
Time frame: Baseline, up to 5 years
Duration of response (DOR)
DOR is defined as time from first occurrence of any response (complete or partial remission) to progression or death, whichever comes first. Analysis will be conducted in the subset of patients with any response.
Time frame: Baseline, up to 5 years
Clinical benefit rate (CBR)
CBR is defined as proportion of patients with complete or partial remission for best response or with stable disease lasting for at least 24 weeks.
Time frame: Baseline, up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE
Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity and seriousness
Time frame: Baseline, up to 30 days after end of tucatinib treatment
Safety laboratory value: Aspartate aminotransferase (AST)
During tucatinib administration, safety laboratory will be performed according to routine clinical practice. Laboratory values of AST (Aspartate aminotransferase) measured will be documented continuously during tucatinib treatment. Baseline levels of AST will be presented using descriptive statistics.
Time frame: Baseline, up to 30 days after end of tucatinib treatment
Safety laboratory value: Alanine aminotransferase (ALT)
During tucatinib administration, safety laboratory will be performed according to routine clinical practice. Laboratory values of ALT (Alanine aminotransferase) measured will be documented continuously during tucatinib treatment. Baseline levels of ALT will be presented using descriptive statistics.
Time frame: Baseline, up to 30 days after end of tucatinib treatment
Safety laboratory value: bilirubin
During tucatinib administration, safety laboratory will be performed according to routine clinical practice. Laboratory values of bilirubin measured will be documented continuously during tucatinib treatment. Baseline levels of bilirubin will be presented using descriptive statistics.
Time frame: Baseline, up to 30 days after end of tucatinib treatment
Therapy decision making
Frequencies and percentages of parameters affecting therapy choice.
Time frame: Baseline
Previous antineoplastic Therapies
Frequency/type of previous systemic antineoplastic treatments (neoadjuvant/adjuvant/palliative)
Time frame: Baseline
Previous anti-HER2 regimens
Frequency and type of previous anti-HER2 based regimens
Time frame: Baseline
Subsequent antineoplastic therapies
Frequency and type of subsequent systemic antineoplastic therapies
Time frame: End of treatment, up to 5 years
Local antineoplastic therapies
Frequency and type of local antineoplastic therapies (surgeries, radiotherapies) incl. local intracranial therapies
Time frame: Baseline, up to 5 years
Details on line of treatment for both cohorts
Cohort 1: frequencies and percentages for line of treatment (1st-line or 2nd-line tucatinib treatment) Cohort 2: frequencies and percentages for line of treatment (3rd-line or 4th-line tucatinib treatment)
Time frame: Baseline
Treatment Duration
Treatment duration of study treatment in total and per substance
Time frame: Baseline, up to 5 years
Dose intensity
Dose intensity (absolute and relative) for each substance as prescribed by the treating physician
Time frame: Baseline, up to 5 years
Dose modifications
Frequency, type and reasons of dose modifications (dose reductions, skipped administrations/delays/interruption) compared to SmPC of tucatinib for each substance.
Time frame: Baseline, up to 5 years
Therapy management (use of relevant supportive medications)
Frequency of usage of antidiarrheal drugs for prophylaxis and treatment of tucatinib-induced diarrhea
Time frame: Baseline, up to 5 years
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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iOMEDICO AG