Personalized coaching to help manage therapy for early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares personalized, typology-based coaching with standard education to see if it extends time to permanent discontinuation of ribociclib in adults with ER-positive, HER2-negative early breast cancer. Participants receive coaching tailored to their patient typology in addition to standard care education and counseling. The study focuses on therapy persistence rather than efficacy endpoints. Enrollment requires consent, confirmed breast cancer subtype, indication for ribociclib with an AI, and adequate organ function. The lead sponsor is Institut fuer Frauengesundheit, with participating centers in Bavaria, Germany.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg
  Augsburg, Bavaria, Germany Recruiting
• Department of Obstetrics and Gynecology, Uniklinikum Erlangen
  Erlangen, Bavaria, Germany Recruiting
• MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
  Hösbach, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Manfred Welslau, Dr. med. — MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie
• Study coordinator: Institut für Frauengesundheit GmbH
• Email: typer@ifg-erlangen.de
• Phone: +49 9131 91880613

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Culmerciclib plus aromatase inhibitors for early ER-positive/HER2-negative breast cancer

  This study tests whether adding culmerciclib to endocrine therapy before surgery helps highly proliferative ER-positive/HER2-negative breast cancer patients see a better response.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07616453

• Fovinaciclib with endocrine therapy and HER2 blockade for HR+/HER2+ early breast cancer

  This study tests whether adding fovinaciclib to endocrine therapy and dual HER2 blockade can shrink HR+/HER2+ breast tumors before surgery, with treatment adapted after an early response.

  Recruiting at 3 sites Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Nanjing, Jiangsu and 2 other locations · NCT07616427

• Improving outcomes for women with high‑risk HR+ early breast cancer taking abemaciclib

  This project looks back at medical records to see if women with high‑risk HR+/HER2‑ early breast cancer are still taking abemaciclib six months after they start treatment.

  Recruiting Institut fuer Frauengesundheit · Erlangen, Bavaria · NCT07531693

• See if standardized coaching helps patients stick with abemaciclib

  This study tests whether structured patient coaching helps women with early HR+/HER2- breast cancer take abemaciclib more reliably alongside endocrine therapy.

  Recruiting at 8 sites Institut fuer Frauengesundheit · Esslingen am Neckar, Baden-Wurttemberg and 7 other locations · NCT07521202

• Ribociclib plus hormone therapy for HR+/HER2- early breast cancer in Saudi Arabia

  This study will try to see if adding ribociclib to standard adjuvant hormone therapy is effective and safe for adults in Saudi Arabia with HR+/HER2- early breast cancer.

  Recruiting at 2 sites Novartis · Riyadh and 1 other locations · NCT06797531

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.