Evaluating ribociclib with aromatase inhibitors for early breast cancer treatment

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 observational study assesses the real-world effectiveness and safety of ribociclib combined with an aromatase inhibitor for patients with HR+/HER2- early breast cancer who are at high risk of recurrence. It aims to gather data on patient compliance, quality of life, and management of adverse events. The study will also compare outcomes with patients receiving other treatment regimens, including abemaciclib and endocrine therapy. Conducted across various breast centers in Germany, it seeks to provide insights into the clinical adoption of ribociclib after its EU approval.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological diagnosis of HR+/HER2- early breast cancer with curative intent
* Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC/"Fachinformation" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC/"Fachinformation" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting
* Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either

  * ribociclib + AI ± LHRH, or
  * ET mono ± LHRH, or
  * abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.

Baseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.

* ≥18 years of age
* Written informed consent

Exclusion Criteria:

\- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.

Where it's running

• Novartis Investigative Site
  Wiener Neustadt, Lower Austria, Austria Recruiting
• Novartis Investigative Site
  Innsbruck, Tyrol, Austria Recruiting
• Novartis Investigative Site
  Linz, Upper Austria, Austria Recruiting
• Novartis Investigative Site
  Graz, Austria Recruiting
• Novartis Investigative Site
  Klagenfurt, Austria Recruiting
• Novartis Investigative Site
  Leoben, Austria Recruiting

+237 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

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

• Improved Facial Skin Quality After VYC-12L for Breast Cancer Survivors

  This study tests whether intradermal injections of VYC-12L can improve facial skin quality and quality of life in adults who have completed breast cancer treatment.

  Recruiting Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Murcia, Murcia · NCT07917117

• Breast cancer subtypes and outcomes in Colombian women

  This study looks back at medical records of women with breast cancer to see how different molecular subtypes relate to survival and recurrence in a single Colombian hospital.

  Recruiting Fundación Santa Fe de Bogota · Bogotá, Bogota D.C. · NCT07856225

• Multimodal psychosomatic symptom care for breast cancer: personalized acupuncture care guided by shared decision-making

  This study tests whether personalized acupuncture options (manual acupuncture, ear acupuncture, or both) can help women with breast cancer who have anxiety, sleep problems, or fatigue, compared to routine nursing care.

  Recruiting at 3 sites First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Tianjin and 2 other locations · NCT07763587

• Slow Jogging for Breast Cancer Survivors

  This study tests whether a 12-week slow jogging program helps sleep quality in women who have completed breast cancer treatment.

  Recruiting Mackay Memorial Hospital · Taipei, Taipei City · NCT07757763

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

• Benchmarking AI language models against tumor boards for oncology treatment decisions

  This project tests whether frontier AI language models can match the treatment recommendations of multidisciplinary tumor boards for common cancers using standardized synthetic cases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Boulogne-Billancourt and 4 other locations · NCT07739121

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.