Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management (TYPER)

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.

Study Overview

• Status: Recruiting
• Conditions: HR+/HER2- Early Breast Cancer
• Intervention / Treatment: Behavioral: Typology-based coaching

• Study Type: Interventional
• Enrollment (Estimated): 548
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Institut für Frauengesundheit GmbH; Phone Number: +49 9131 91880613; Email: typer@ifg-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
      • Contact: Nina Ditsch, Prof. Dr. med.; Phone Number: +49 821 400165809; Email: nina.ditsch@uk-augsburg.de
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Department of Obstetrics and Gynecology, Uniklinikum Erlangen
      • Contact: Peter A. Fasching, Prof. Dr. med.; Phone Number: +49 9131 8533572; Email: fk-studienzentrale@uk-erlangen.de
    • Hösbach, Bavaria, Germany, 63768
      • Recruiting
      • MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
      • Contact: Manfred Welslau, Dr. med.; Phone Number: +49 6021 4527391; Email: manfred.welslau@mvz-klinikum-ab.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Typology-based coaching; Personalized therapy coaching based on patient typology	Behavioral: Typology-based coaching; Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
No Intervention: Standard of care patient counselling; Standard of care therapy education and counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discontinuation	Time to permanent discontinuation of ribociclib therapy	From baseline up to end of study (max. 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ribociclib persistence rate	Ribociclib persistence rate (defined as ongoing ribociclib therapy)	At 6, 12 and 36 months after therapy start

Collaborators and Investigators

• Sponsor: Institut fuer Frauengesundheit
• Investigators: Principal Investigator: Manfred Welslau, Dr. med., MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie; Principal Investigator: Nina Ditsch, Prof. Dr. med., Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IFG-01-2024; 2024-520290-12-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No