Clinical Research Directory

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.