Coaching may boost adherence to breast cancer therapy
NCT ID NCT07708571
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests whether personalized coaching based on patient typology helps women with HR+/HER2- early breast cancer stick with their ribociclib treatment longer. About 548 participants will either receive standard education or tailored coaching using a validated tool. The goal is to see if coaching reduces early treatment discontinuation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- typology-based coaching (behavioral intervention using the MOATT tool)
- What this could lead to
- If successful, this coaching approach could help more patients complete their ribociclib treatment, potentially improving outcomes for early breast cancer.
- What could go wrong
- This is a behavioral study, not a drug trial, so the impact may be modest. Coaching might not significantly change how long patients stay on therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 548 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
RECRUITINGAugsburg, Bavaria, 86156, Germany
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Department of Obstetrics and Gynecology, Uniklinikum Erlangen
RECRUITINGErlangen, Bavaria, 91054, Germany
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MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
RECRUITINGHösbach, Bavaria, 63768, Germany
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- Coaching may boost cancer pill adherence in new study