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RecruitingNCT07708571TYPERUpdated Jul 16, 2026

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

An interventional study of Typology-based coaching in HR+/HER2- Early Breast Cancer, sponsored by Institut fuer Frauengesundheit. Recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Institut fuer Frauengesundheit · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2025, registered Jul 2026).
  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
548
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • HR+/HER2- Early Breast Cancer
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In context

Lead sponsor

Institut fuer Frauengesundheit is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
548 participants (estimated)

Study arms

  • Experimental
    Typology-based coaching

    Personalized therapy coaching based on patient typology

    Behavioral: Typology-based coaching

  • No intervention
    Standard of care patient counselling

    Standard of care therapy education and counselling

Interventions

  • BehavioralTypology-based coaching

    Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)

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What researchers measure

Primary outcomes

  1. Time to discontinuation

    Time to permanent discontinuation of ribociclib therapy

    Time frame: From baseline up to end of study (max. 5 years)

Secondary outcomes

  1. Ribociclib persistence rate

    Ribociclib persistence rate (defined as ongoing ribociclib therapy)

    Time frame: At 6, 12 and 36 months after therapy start

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Study locations

3 of 3 sites recruiting
  • Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
    Augsburg, Bavaria 86156, Germany
    Recruiting
  • Department of Obstetrics and Gynecology, Uniklinikum Erlangen
    Erlangen, Bavaria 91054, Germany
    Recruiting
  • MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
    Hösbach, Bavaria 63768, Germany
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07708571
Lead sponsor
Institut fuer Frauengesundheit
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Nov 4, 2025
Primary completion
Jun 2030 (estimated)
Completion
Jun 2030 (estimated)
Last update
Jul 16, 2026

Study contacts

Institut für Frauengesundheit GmbH
Contact
typer@ifg-erlangen.de
+49 9131 91880613
Manfred Welslau, Dr. med.
principal investigator · MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
Nina Ditsch, Prof. Dr. med.
principal investigator · Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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