Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management (TYPER)
13. juli 2026 oppdatert av: Institut fuer Frauengesundheit
A Randomized Controlled Study Evaluating the Effectiveness of Typology-based Coaching on Therapy Management for Patients With HRpos/HER2neg Early Breast Cancer Under Adjuvant Treatment With Ribociclib
The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib.
Researchers will compare the time to permanent treatment discontinuation of patients receiving personalized coaching to the time to permanent treatment discontinuation of patients who only receive standard of care education and counselling, to see if adherence to treatment can be improved by personalized patient coaching.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
548
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Institut für Frauengesundheit GmbH
- Telefonnummer: +49 9131 91880613
- E-post: typer@ifg-erlangen.de
Studiesteder
-
-
Bavaria
-
Augsburg, Bavaria, Tyskland, 86156
- Rekruttering
- Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
-
Ta kontakt med:
- Nina Ditsch, Prof. Dr. med.
- Telefonnummer: +49 821 400165809
- E-post: nina.ditsch@uk-augsburg.de
-
Erlangen, Bavaria, Tyskland, 91054
- Rekruttering
- Department of Obstetrics and Gynecology, Uniklinikum Erlangen
-
Ta kontakt med:
- Peter A. Fasching, Prof. Dr. med.
- Telefonnummer: +49 9131 8533572
- E-post: fk-studienzentrale@uk-erlangen.de
-
Hösbach, Bavaria, Tyskland, 63768
- Rekruttering
- MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
-
Ta kontakt med:
- Manfred Welslau, Dr. med.
- Telefonnummer: +49 6021 4527391
- E-post: manfred.welslau@mvz-klinikum-ab.de
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Participant provides written informed consent prior to the beginning of trial-specific procedures.
- Patients must be aged ≥18 years on the day of signing informed consent.
- Participant has histologically confirmed primary invasive adenocarcinoma of the breast.
- Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or progesterone receptor-positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory.
- Participant has HER2neg breast cancer defined as a negative ISH test or an IHC status of 0, 1+, or 2+. If the IHC is 2+, a negative ISH (e.g., FISH, CISH, SISH, or DISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
- Indication for treatment with ribociclib in combination with an aromatase inhibitor for early breast cancer according to the valid SmPC.
- Participant has adequate organ function amenable for treatment with ribociclib as assessed by a local laboratory.
- Female participants of childbearing potential must have had a hysterectomy or be willing to use highly effective methods of contraception and have a confirmed negative pregnancy test as assessed by local in-house standard.
- Participant is willing and able to comply with scheduled visits, treatment plans, and other trial procedures.
Exclusion Criteria:
- Patients with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Patients with serious preexisting medical condition(s) that would preclude participation in this study.
- Women who are pregnant or lactating.
- Patients with active bacterial infections (requiring IV antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (e.g., known human immunodeficiency virus positivity or known active hepatitis B or C, such as hepatitis B surface antigen-positive]).
- Patients with a personal history in the past 5 years of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- Patients with contraindications against ribociclib according to the current SmPC.
- Patients with hypersensitivity to active substance of ribociclib, peanuts, soya or one of the other ingredients
- Patients who are not eligible for the trial due to severe comorbidities other than those mentioned above or unavailability according to the treating physician.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Typology-based coaching
Personalized therapy coaching based on patient typology
|
Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
|
|
Ingen inngripen: Standard of care patient counselling
Standard of care therapy education and counselling
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to discontinuation
Tidsramme: From baseline up to end of study (max. 5 years)
|
Time to permanent discontinuation of ribociclib therapy
|
From baseline up to end of study (max. 5 years)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ribociclib persistence rate
Tidsramme: At 6, 12 and 36 months after therapy start
|
Ribociclib persistence rate (defined as ongoing ribociclib therapy)
|
At 6, 12 and 36 months after therapy start
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Manfred Welslau, Dr. med., MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
- Hovedetterforsker: Nina Ditsch, Prof. Dr. med., Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. november 2025
Primær fullføring (Antatt)
1. juni 2030
Studiet fullført (Antatt)
1. juni 2030
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IFG-01-2024
- 2024-520290-12-00 (Ctis)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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