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

NCT05253911 | Completed

• 1 other identifier: IOM-120465
• Study Type: observational
• Target: 49
• Locations: 2 countries
• Sites: 2

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 breast cancer who have been previously treated with at least two anti-HER2 treatment regimens in a real-world setting,

Conditions

HER2-positive Breast Cancer

Keywords

HER2-positive breast cancer; Tucatinib

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, up to 24 months

Secondary Outcomes (19)

• Time to next systemic treatment (TTNT)

  Baseline, up to 5 years

• Time to local intracranial treatment (TLT)

  Baseline, up to 5 years

• Overall response rate (ORR)

  Baseline, up to 5 years

• Duration of response (DOR)

  Baseline, up to 5 years

• Clinical benefit rate (CBR)

  Baseline, up to 5 years

Study Arms (2)

Cohort 1

Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 1st or 2nd palliative therapy line.

Drug: TUKYSA®

Cohort 2

Patients receiving tucatinib/trastuzumab/capecitabine (=study treatment) in 3rd or 4th palliative therapy line.

Drug: TUKYSA®

Interventions

TUKYSA® DRUG

tucatinib/trastuzumab/capecitabine according to TUKYSA® SmPC.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• st/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.
• Knowledge of German language.
• Other criteria according to current SmPC of tucatinib

You may not qualify if:

• 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)

Sponsors & Collaborators

• iOMEDICO AG: lead
• Seagen Germany GmbH (a Pfizer company): collaborator

Study Sites (2)

Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie

Vienna, 1090, Austria

Location

Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

Essen, North Rhine-Westphalia, D-45112, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All patients will be asked to give additional informed consent agreeing that their routinely collected tumor samples could be used for further translational research.

MeSH Terms

Interventions

tucatinib

Study Officials

• Anja Welt, PD Dr.

  Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

  STUDY CHAIR

• Rupert Bartsch, Assoc. Prof. PD Dr.

  Medical University of Vienna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 24, 2022
• Study Start: May 21, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); AU (1)