An observational study in HR+HER2- Advanced Breast Cancer, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 20 sites in Russia. Open to participants aged 65 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Novartis Pharmaceuticals · Observational
This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.
In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
elderly patients with HR+HER2- advanced breast cancer
Exclusion Criteria:
change of QoL (RAND SF-36)
The primary endpoint of the study is the change of QoL during treatment with ribociclib+ET from baseline to the level at 12 months (RAND SF-36) across all age's subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and depend on treatment lines (first-line (1L) or in second-line (2L) settings)
Time frame: from baseline to the level at 12 months
Time to treatment failure (TTF)
Time to treatment failure (TTF) in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)
Time frame: up to two years
Progression free survival rate (PFS)
Progression free survival rate (PFS) at 24 months in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)
Time frame: up to two years
Median progression free survival
Median progression free survival (if reached) in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)
Time frame: up tp two years
Overall survival rate (OS)
Overall survival rate (OS) at 24 months in HR+/HER2- aBC women initiating treatment with ribociclib+ET in across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)
Time frame: up to two years
Objective response rate (ORR)
Objective response rate (ORR) as assessed by the investigator in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L)
Time frame: up to two years
Clinical benefit rate (CBR)
Clinical benefit rate (CBR) as assessed by the investigator in HR+/HER2- aBC women initiating treatment with ribociclib+ET across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) depend on treatment lines (1L or 2L).
Time frame: up to two years
Proportions (%) of patients and reasons of permanent discontinuation of ribociclib
Proportions (%) of patients and reasons of permanent discontinuation of ribociclib
Time frame: up to two years
Proportions (%) of patients and reasons of dose adjustment on ribocicli
Proportions (%) of patients and reasons of dose adjustment on ribocicli
Time frame: up to two years
Adverse events (AEs) frequency and severity
Adverse events (AEs) frequency and severity
Time frame: up to two years
Quality of life (RAND SF-36, questionnaire of patient's satisfaction)
Quality of life (RAND SF-36, questionnaire of patient's satisfaction) during treatment with ribociclib + ET (AI/FUL) across all age subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and in first-line (1L) and in second-line (2L) settings
Time frame: up to two years
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals