Anja Welt, PD Dr. Study Chair Universitätsklinikum Essen, Innere Klinik (Tumorforschung) Rupert Bartsch, Assoc. Prof. PD Dr. Study Chair Medical University of Vienna
Kontakt
Cathrin Hogrefe, Dr. Kontakt: Phone: +49761152420 E-Mail: Trace@iomedico.com» Kontaktdaten anzeigen
Studienlocations (2 von 2)
Universitätsklinikum Essen, Innere Klinik (Tumorforschung) D-45112 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Anja Welt, PD Dr. Phone: +492017233100 E-Mail: anja.welt@uk-essen.de» Ansprechpartner anzeigenMedizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie 1090 Vienna AustriaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Rupert Bartsch, Assoc. Prof. PD Dr. Phone: +43 14040044450 E-Mail: rupert.bartsch@meduniwien.ac.at» Ansprechpartner anzeigen
1. Time to deterioration of EORTC global health scale by at least 10 points (Time Frame - Baseline, up to 24 months): 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.
2. Changes in the global health scale (Time Frame - Baseline, up to 24 months): 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.
Secondary outcome:
1. Time to next systemic treatment (TTNT) (Time Frame - Baseline, up to 5 years): 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.
2. Time to local intracranial treatment (TLT) (Time Frame - Baseline, up to 5 years): 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.
3. Overall survival (OS) (Time Frame - Baseline, up to 5 years): OS is defined as time from first administration of any study treatment to death from any cause.
4. Overall response rate (ORR) (Time Frame - Baseline, up to 5 years): ORR is defined as proportion of patients with any response (partial or complete remission) overall.
5. Duration of response (DOR) (Time Frame - Baseline, up to 5 years): 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.
6. Clinical benefit rate (CBR) (Time Frame - Baseline, up to 5 years): 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.
7. Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE (Time Frame - Baseline, up to 30 days after end of tucatinib treatment): Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity and seriousness
8. Safety laboratory value: Aspartate aminotransferase (AST) (Time Frame - Baseline, up to 30 days after end of tucatinib treatment): During tucatinib administration, safety laboratory will be performed according to routine clinical practice. Laboratory values of AST (Aspartate aminotransferase) measured will be documented continously during tucatinib treatment. Baseline levels of AST will be presented using descriptive statistics.
9. Safety laboratory value: Alanine aminotransferase (ALT) (Time Frame - Baseline, up to 30 days after end of tucatinib treatment): During tucatinib administration, safety laboratory will be performed according to routine clinical practice. Laboratory values of ALT (Alanine aminotransferase) measured will be documented continously during tucatinib treatment. Baseline levels of ALT will be presented using descriptive statistics.
10. Safety laboratory value: bilirubin (Time Frame - Baseline, up to 30 days after end of tucatinib treatment): During tucatinib administration, safety laboratory will be performed according to routine clinical practice. Laboratory values of bilirubin measured will be documented continously during tucatinib treatment. Baseline levels of bilirubin will be presented using descriptive statistics.
11. Therapy decision making (Time Frame - Baseline): Frequencies and percentages of parameters affecting therapy choice.
13. Previous anti-HER2 regimens (Time Frame - Baseline): Frequency and type of previous anti-HER2 based regimens
14. Subsequent antineoplastic therapies (Time Frame - End of treatment, up to 5 years): Frequency and type of subsequent systemic antineoplastic therapies
15. Local antineoplastic therapies (Time Frame - Baseline, up to 5 years): Frequency and type of local antineoplastic therapies (surgeries, radiotherapies) incl. local intracranial therapies
16. Details on line of treatment for both cohorts (Time Frame - Baseline): 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)
17. Treatment Duration (Time Frame - Baseline, up to 5 years): Treatment duration of study treatment in total and per substance
18. Dose intensity (Time Frame - Baseline, up to 5 years): Dose intensity (absolute and relative) for each substance as prescribed by the treating physician
19. Dose modifications (Time Frame - Baseline, up to 5 years): Frequency, type and reasons of dose modifications (dose reductions, skipped administrations/delays/interruption) compared to SmPC of tucatinib for each substance.
20. Therapy management (use of relevant supportive medications) (Time Frame - Baseline, up to 5 years): Frequency of usage of antidiarrheal drugs for prophylaxis and treatment of tucatinib-induced diarrhea
