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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | from baseline to the level at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to two years |
| Progression free survival rate (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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elderly patients with HR+HER2- advanced breast cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Arkhangelsk | 163045 | Russia | |||
| Novartis Investigative Site |
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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) |
| 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) | 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) | 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) | 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). | up to two years |
| Proportions (%) of patients and reasons of permanent discontinuation of ribociclib | Proportions (%) of patients and reasons of permanent discontinuation of ribociclib | up to two years |
| Proportions (%) of patients and reasons of dose adjustment on ribocicli | Proportions (%) of patients and reasons of dose adjustment on ribocicli | up to two years |
| Adverse events (AEs) frequency and severity | Adverse events (AEs) frequency and severity | 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 | up to two years |
| Barnaul |
| 656045 |
| Russia |
| Novartis Investigative Site | Bryansk | 241028 | Russia |
| Novartis Investigative Site | Chelyabinsk | 454080 | Russia |
| Novartis Investigative Site | Irkutsk | 664035 | Russia |
| Novartis Investigative Site | Kemerovo | 650036 | Russia |
| Novartis Investigative Site | Khabarovsk | 680042 | Russia |
| Novartis Investigative Site | Khanty-Mansiysk | 628012 | Russia |
| Novartis Investigative Site | Kirov | 610021 | Russia |
| Novartis Investigative Site | Krasnoyarsk | 660022 | Russia |
| Novartis Investigative Site | Obninsk | 249036 | Russia |
| Novartis Investigative Site | Perm | 614066 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344006 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194291 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Tambov | 392000 | Russia |
| Novartis Investigative Site | Tver' | 170008 | Russia |
| Novartis Investigative Site | Ufa | 450054 | Russia |
| Novartis Investigative Site | Yaroslavl | 150054 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620036 | Russia |