Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
548
Countries
1
Sites
20
Hormone receptor–positive (HRpos)/human epidermal growth factor receptor 2–negative (HER2neg) early breast cancer at risk of recurrence
The primary objective of this study is to evaluate the effect of patient education and typology-based coaching on treatment persistence. The primary endpoint will be the time to permanent treatment discontinuation of ribociclib therapy.
Key facts
- Sponsor
- Institut fuer Frauengesundheit GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Nov 2025 → ongoing
- Decision date (initial)
- 2025-08-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novartis Pharma GmbH
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Others
The primary objective of this study is to evaluate the effect of patient education and typology-based coaching on treatment persistence. The primary endpoint will be the time to permanent treatment discontinuation of ribociclib therapy.
Secondary objectives 8
- To assess the overall persistence rate at month 6, 12 and 36 (planned end of ribociclib treatment)
- To assess the relapse- and death-free discontinuation rate at month 6, 12, 36
- To assess the frequency and duration of patient- and physician-decided therapy interruptions
- To assess patient distress and quality of life
- To evaluate the tolerability and safety profile of ribociclib treatment
- To assess the invasive disease-free survival (iDFS), distant disease-free survival (DDFS), and overall survival (OS)
- To assess health utilities (healthcare provision resources)
- To evaluate the change in patient typology over time
Conditions and MedDRA coding
Hormone receptor–positive (HRpos)/human epidermal growth factor receptor 2–negative (HER2neg) early breast cancer at risk of recurrence
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Trial Period After providing written informed consent, study participants will be registered into the electronic case form report (eCRF) and randomized at a 1:1 ratio through an interactive response technology system to receive either standard patient management (control arm) or personalized (study arm). All patients—irrespective of their allocated study arm—will receive treatment with ribociclib in combination with endocrine therapy.
|
Randomised Controlled | None | Study Arm: Patients randomized in this arm will receive intensified, personalized coaching on adjuvant therapy. Control Arm: Patients will be treated according to standard of care. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- 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 8
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- time to permanent treatment discontinuation of ribociclib therapy
Secondary endpoints 8
- overall persistence rate at 6, 12 and 36 months of adjuvant ribociclib therapy
- relapse- and death-free discontinuation rate at 6,12 and 36 months of adjuvant ribociclib therapy
- total time of therapy interruptions within 36 months of ribociclib treatment, surveyed by a patient diary
- distress and quality of life assessed via the Functional Assessment of Cancer Therapy—Breast (FACT-B), the EQ-5D/visual analog scale (VAS) questionnaires, and the patient distress thermometer after 3, 6, 9, 12, 24, and 36 months of treatment
- frequency of adverse events (AEs) (serious AEs (SAEs) will be reported according to National Cancer Institute (NCI) Common Toxicity Criteria version 5.0)
- outcomes according to STEEP 2.0 criteria
- required health utilities within 12, 24 and 36 months
- patient type before coaching and after 12 months of coaching
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kisqali 200 mg film-coated tablets
PRD5341538 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut fuer Frauengesundheit GmbH
- Sponsor organisation
- Institut fuer Frauengesundheit GmbH
- Address
- Hindenburgstrasse 50, Innenstadt Innenstadt
- City
- Erlangen
- Postcode
- 91054
- Country
- Germany
Scientific contact point
- Organisation
- Institut fuer Frauengesundheit GmbH
- Contact name
- Clinical Trial Team
Public contact point
- Organisation
- Institut fuer Frauengesundheit GmbH
- Contact name
- Clinical Trial Team
Locations
1 EU/EEA country · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 548 | 20 |
| Rest of world | — | 0 | — |
Investigational sites
Gesundheit Nord gGmbH Klinikverbund Bremen
Klinik für Gynäkologie, Gynäkoonkologie und Senologie, St.-Juergen-Strasse 1, Hulsberg, Bremen
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Gynäkologie, Studienzentrale, Martinistrasse 52, Eppendorf, Hamburg
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Haematology and Oncology, Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
Universitaetsklinikum Regensburg AöR
Klinik für Frauenheilkunde und Geburtshilfe, Landshuter Strasse 65, Kasernenviertel, Regensburg
Universitaetsklinikum Bonn AöR
Zentrum für Geburtshilfe und Frauenheilkunde/ Brustzentrum, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Augsburg
Gynecology and Obstetrics, Stenglinstrasse 2, Kriegshaber, Augsburg
Medicum Rosenheim MVZ GmbH
Haematology and Oncology, Stollstraße 6, 83022, Rosenheim
Klinikum Esslingen GmbH
Frauenklinik, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Universitaetsklinikum des Saarlandes AöR
Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin, Kirrberger Strasse 100, 66421, Homburg
Marienhospital Bottrop gGmbH
Gynecology and Obstetrics, Josef-Albers-Strasse 70, Sued-West-Innenstadt, Bottrop
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Gynäkologie, Feldstrasse 16, Innenstadt, Trier
University Hospital Cologne AöR
Klinik für Frauenheilkunde und Geburtshilfe, Kerpener Strasse 62, Lindenthal, Cologne
ANregiomed gKU AöR des Landkreises Ansbach und der Stadt Ansbach
Brustzentrum Mittelfranken, Escherichstrasse 1, 91522, Ansbach
Klinikum Kulmbach
Gynecology and Obstetrics, Albert-Schweitzer-Strasse 10, Blaich, Kulmbach
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Evangelisches Krankenhaus Bergisch Gladbach gGmbH
Gynäkologie, Ferrenbergstrasse 24, Gladbach, Bergisch Gladbach
Klinikum Ernst von Bergmann gGmbH
Brustzentrum, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Rotkreuzklinikum Muenchen gGmbH
Frauenklinik, Taxisstrasse 3, Neuhausen-Nymphenburg, Munich
MVZ am Klinikum Aschaffenburg GmbH
Haematology and Oncology, Industriestr. 2, 63768, Hösbach
Universitaetsklinikum Erlangen AöR
Frauenklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-11-04 | 2025-11-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Coaching Reference Book _V1_0_TYPER_2025-05-13 | 1 |
| Protocol (for publication) | TYPER_Trial Protocol_V1_0_2025_05_05_redacted | 1 |
| Protocol (for publication) | TYPER_Trial Protocol_V1_1_TC | 1 |
| Recruitment arrangements (for publication) | TYPER_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | TYPER_Consent Procedures | 1 |
| Subject information and informed consent form (for publication) | TYPER_ICFV1_0_2025-04-25_FINAL | 1 |
| Subject information and informed consent form (for publication) | TYPER_ICFV1_1_2025-07-28_TC | 1.1 |
| Subject information and informed consent form (for publication) | TYPER_Zusatz ICF_Biobanking_V1_0_final | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Kisqali | V022 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-02 | Germany | Acceptable 2025-08-11
|
2025-08-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-09 | Germany | Acceptable 2026-04-15
|
2026-04-27 |