RIBOCICLIB for Hormone receptor-positive HER2-negative early breast cancer | Breast cancer

Inclusion criteria

• {"criterion_text":"- Participant provides written informed consent prior to the beginning of trial-specific procedures\n- Patients must be aged ≥18 years on the day of signing informed consent\n- Participant has histologically confirmed primary invasive adenocarcinoma of the breast\n- 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\n- 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\n- Indication for treatment with ribociclib in combination with an aromatase inhibitor for early breast cancer according to the valid SmPC\n- Participant has adequate organ function amenable for treatment with ribociclib as assessed by a local laboratory\n- 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\n- Participant is willing and able to comply with scheduled visits, treatment plans, and other trial procedures"}

Exclusion criteria

• {"criterion_text":"- 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\n- Patients with serious preexisting medical condition(s) that would preclude participation in this study\n- Women who are pregnant or lactating\n- 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])\n- 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\n- Patients with contraindications against ribociclib according to the current SmPC\n- Patients with hypersensitivity to active substance of ribociclib, peanuts, soya or one of the other ingredients\n- Patients who are not eligible for the trial due to severe comorbidities other than those mentioned above or unavailability according to the treating physician"}

Primary endpoints

• {"endpoint_text":"- time to permanent treatment discontinuation of ribociclib therapy","definition_or_measurement_approach":"As stated: time to permanent treatment discontinuation of ribociclib therapy (primary objective/end point described in the trial objective)."}

Secondary endpoints

• {"endpoint_text":"- overall persistence rate at 6, 12 and 36 months of adjuvant ribociclib therapy","definition_or_measurement_approach":"Persistence rate measured at months 6, 12 and 36 of adjuvant ribociclib therapy (as stated)."}
• {"endpoint_text":"- relapse- and death-free discontinuation rate at 6,12 and 36 months of adjuvant ribociclib therapy","definition_or_measurement_approach":"Relapse- and death-free discontinuation rate measured at months 6, 12 and 36 (as stated)."}
• {"endpoint_text":"- total time of therapy interruptions within 36 months of ribociclib treatment, surveyed by a patient diary","definition_or_measurement_approach":"Total duration of therapy interruptions within 36 months, as recorded via patient diary (explicitly stated)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Patient-reported outcomes measured using FACT-B, EQ-5D/VAS and patient distress thermometer at specified timepoints (3,6,9,12,24,36 months)."}
• {"endpoint_text":"- frequency of adverse events (AEs) (serious AEs (SAEs) will be reported according to National Cancer Institute (NCI) Common Toxicity Criteria version 5.0)","definition_or_measurement_approach":"AE frequency collection; SAEs to be reported per NCI CTCAE v5.0 (explicitly stated)."}
• {"endpoint_text":"- outcomes according to STEEP 2.0 criteria","definition_or_measurement_approach":"Outcomes classified and reported according to STEEP 2.0 criteria (as stated)."}
• {"endpoint_text":"- required health utilities within 12, 24 and 36 months","definition_or_measurement_approach":"Health utility measures collected at months 12, 24 and 36 (as stated)."}
• {"endpoint_text":"- patient type before coaching and after 12 months of coaching","definition_or_measurement_approach":"Change in patient typology assessed before coaching and after 12 months (as stated)."}

Germany

Earliest CTIS Part Ii Submission Date

01-08-2025

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

270

Number Of Sites

20

Number Of Participants

548

Primary sponsor

Full Name

Institut fuer Frauengesundheit GmbH

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany