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

Last updated: October 15, 2024
Sponsor: iOMEDICO AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

TUKYSA®

Clinical Study ID

NCT05253911
IOM-120465
  • Ages > 18
  • All Genders

Study 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,

Eligibility Criteria

Inclusion

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 patientswith brain metastases.

  • Prior treatment with at least two prior anti-HER2-based regimens.

  • Decision for treatment with tucatinib in combination with trastuzumab andcapecitabine 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, notapplicable for retrospective inclusion of deceased patients).

  • Knowledge of German language.

  • Other criteria according to current SmPC of tucatinib

Exclusion

Exclusion Criteria:

  • Contraindications according to SmPC of tucatinib

  • Participation in an interventional clinical trial within 30 days prior to enrolmentor simultaneous participation in an interventional clinical trial.

  • Treatment with tucatinib/trastuzumab/capecitabine (=study treatment) in 5th orhigher palliative therapy line.

  • Onset of tucatinib treatment later than 22 days after start of therapy line (in casetucatinib administration is started later than trastuzumab and/or capecitabine forany reason)

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: TUKYSA®
Phase:
Study Start date:
May 21, 2022
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

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

    Vienna, 1090
    Austria

    Site Not Available

  • Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

    Essen, Northrhine-Westphalia D-45112
    Germany

    Active - Recruiting

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