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HER2-positive Breast CancerTRACENCT05253911

Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.

An observational study of HER2-positive Breast Cancer, run by iOMEDICO AG at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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, Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
TUKYSA®
How many people
49 participants
Where
2 sitesin 2 countries
Study dates
21 May 2022to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie

    Vienna, 1090

Other trials in Austria

Germany1 site

  • Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

    Essen, North Rhine-Westphalia, D-45112

Other trials in Germany

About this study

Official title: 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)

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,

Read the 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 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.

Being tested
TUKYSA®
Keywords
HER2-positive breast cancer, Tucatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TUKYSA®Drug

    tucatinib/trastuzumab/capecitabine according to TUKYSA® SmPC.

Study groups in NCT05253911
Study groupRoleWhat they receive
Cohort 1Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 1st or 2nd palliative therapy line.
Receives: Drug: TUKYSA®
Cohort 2Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 3rd or 4th palliative therapy line.
Receives: Drug: TUKYSA®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, up to 24 months

  2. 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.

    Measured: Baseline, up to 24 months

Secondary outcomes (19)

  1. 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.

    Measured: Baseline, up to 5 years

  2. 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.

    Measured: Baseline, up to 5 years

  3. Overall response rate (ORR)

    ORR is defined as proportion of patients with any response (partial or complete remission) overall.

    Measured: Baseline, up to 5 years

  4. 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.

    Measured: Baseline, up to 5 years

  5. 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.

    Measured: Baseline, up to 5 years

  6. 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

    Measured: Baseline, up to 30 days after end of tucatinib treatment

  7. 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.

    Measured: Baseline, up to 30 days after end of tucatinib treatment

  8. 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.

    Measured: Baseline, up to 30 days after end of tucatinib treatment

  9. 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.

    Measured: Baseline, up to 30 days after end of tucatinib treatment

  10. Therapy decision making

    Frequencies and percentages of parameters affecting therapy choice.

    Measured: Baseline

  11. Previous antineoplastic Therapies

    Frequency/type of previous systemic antineoplastic treatments (neoadjuvant/adjuvant/palliative)

    Measured: Baseline

  12. Previous anti-HER2 regimens

    Frequency and type of previous anti-HER2 based regimens

    Measured: Baseline

  13. Subsequent antineoplastic therapies

    Frequency and type of subsequent systemic antineoplastic therapies

    Measured: End of treatment, up to 5 years

  14. Local antineoplastic therapies

    Frequency and type of local antineoplastic therapies (surgeries, radiotherapies) incl. local intracranial therapies

    Measured: Baseline, up to 5 years

  15. 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)

    Measured: Baseline

  16. Treatment Duration

    Treatment duration of study treatment in total and per substance

    Measured: Baseline, up to 5 years

  17. Dose intensity

    Dose intensity (absolute and relative) for each substance as prescribed by the treating physician

    Measured: Baseline, up to 5 years

  18. Dose modifications

    Frequency, type and reasons of dose modifications (dose reductions, skipped administrations/delays/interruption) compared to SmPC of tucatinib for each substance.

    Measured: Baseline, up to 5 years

  19. Therapy management (use of relevant supportive medications)

    Frequency of usage of antidiarrheal drugs for prophylaxis and treatment of tucatinib-induced diarrhea

    Measured: Baseline, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start21 May 2022
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253911
Sponsor's protocol ID
IOM-120465
Acronym
TRACE
Status last verified
Nov 2025
First submitted
1 Feb 2022
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HER2-positive Breast Cancer, run by iOMEDICO AG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to deterioration of EORTC global health scale by at least 10 points (time frame: Baseline, up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05253911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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