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Ribociclib / aplelicib / mono endocrine therapy · Observational Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed prospective observational registry study of HR+/HER2− advanced breast cancer patients initiating ribociclib, alpelisib, endocrine therapy, or chemotherapy in routine Russian clinical practice. No efficacy, safety, or outcome results are reported in this registry record; only study design and enrollment are documented.
Observational. Breast Cancer; Female; age from 18 Years; to 99 Years. Intervention: ribociclib + AI/fulvestrant; aplelicib + fulvestrant; mono endocrine therapy; chemotherapy. Compared with: Multiple treatment arms compared observationally; no randomized control group.. n = 2,390. 58 sites: Russia.
This is a completed prospective observational registry study of HR+/HER2− advanced breast cancer patients initiating ribociclib, alpelisib, endocrine therapy, or chemotherapy in routine Russian clinical practice. No efficacy, safety, or outcome results are reported in this registry record; only study design and enrollment are documented.
Registry record contains no outcome data, efficacy results, safety data, or statistical analyses. No baseline characteristics, adverse events, or comparative effectiveness metrics reported in this entry.
This observational record provides no clinical data in its current form. Once results are published, it may contribute to understanding real-world treatment patterns and outcomes for HR+/HER2− advanced breast cancer in Russia, but comparative efficacy or safety conclusions cannot yet be drawn from this registry entry alone.
This is a completed prospective observational registry study with no results posted; it describes treatment patterns and outcomes in routine practice but carries no efficacy or safety data in this record.
As stated by the source record.
Quoted from the source exactly as published.
This observational record provides no clinical data in its current form. Once results are published, it may contribute to understanding real-world treatment patterns and outcomes for HR+/HER2− advanced breast cancer in Russia, but comparative efficacy or safety conclusions cannot yet be drawn from this registry entry alone.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04943497). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 2390 participants (ACTUAL). Conditions: Breast Cancer. Interventions: OTHER: ribociclib; OTHER: aplelicib; OTHER: mono endocrine therapy; OTHER: chemotherapy. Primary outcome measures: Time to treatment failure (TTF) , Up to 24 months. Brief summary: This study was planned as a prospective multicenter NIS. This study was observational in nature and did not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy were included in the study across seven Russian districts.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.