HR+/HER2- Early Breast CancerTYPERNCT07708571
Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management
A study testing Typology-based coaching in people with HR+/HER2- Early Breast Cancer, run by Institut fuer Frauengesundheit at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+/HER2- Early Breast Cancer
- What is being tested?
- Typology-based coaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 3 sitesGermany
- Study dates
- 4 Nov 2025to Jun 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156
Nina Ditsch, Prof. Dr. med., +49 821 400165809, nina.ditsch@uk-augsburg.de
- Recruiting
Department of Obstetrics and Gynecology, Uniklinikum Erlangen
Erlangen, Bavaria, 91054
Peter A. Fasching, Prof. Dr. med., +49 9131 8533572, fk-studienzentrale@uk-erlangen.de
- Recruiting
MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
Hösbach, Bavaria, 63768
Manfred Welslau, Dr. med., +49 6021 4527391, manfred.welslau@mvz-klinikum-ab.de
About this study
Official title: 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.
- Conditions
- HR+/HER2- Early Breast Cancer
- Being tested
- Typology-based coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typology-based coachingBehavioural
Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
| Study group | Role | What they receive |
|---|---|---|
| Typology-based coaching | Experimental | Personalized therapy coaching based on patient typology Receives: Behavioral: Typology-based coaching |
| Standard of care patient counselling | No intervention | Standard of care therapy education and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinuation
Time to permanent discontinuation of ribociclib therapy
Measured: From baseline up to end of study (max. 5 years)
Secondary outcomes (1)
Ribociclib persistence rate
Ribociclib persistence rate (defined as ongoing ribociclib therapy)
Measured: At 6, 12 and 36 months after therapy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start4 Nov 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Early Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manfred Welslau, Dr. med., Principal investigator, MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und OnkologieNina Ditsch, Prof. Dr. med., Principal investigator, Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708571
- Sponsor's protocol ID
- IFG-01-2024
- Other IDs
- 2024-520290-12-00
- Acronym
- TYPER
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No