HR+HER2- Advanced Breast Cancer
Conditions
Keywords
HR+HER2- advanced breast cancer, ribociclib, elderly patients
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 65 years at the moment of ribociclib+ET initiation 2. Female/Male gender 3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment 4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study 5. Provision of written informed consent.
Exclusion criteria
1. Patients with a life expectancy of less than 3 months per the investigator's judgment 2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study) 3. Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis 4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of QoL (RAND SF-36) | from baseline to the level at 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment failure (TTF) | up to two years | 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) |
| Progression free survival rate (PFS) | up to two years | 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) |
| Median progression free survival | up tp two years | 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) |
| Overall survival rate (OS) | up to two years | 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) |
| Objective response rate (ORR) | up to two years | 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) |
| Clinical benefit rate (CBR) | up to two years | 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). |
| Proportions (%) of patients and reasons of permanent discontinuation of ribociclib | up to two years | Proportions (%) of patients and reasons of permanent discontinuation of ribociclib |
| Proportions (%) of patients and reasons of dose adjustment on ribocicli | up to two years | Proportions (%) of patients and reasons of dose adjustment on ribocicli |
| Adverse events (AEs) frequency and severity | up to two years | Adverse events (AEs) frequency and severity |
| Quality of life (RAND SF-36, questionnaire of patient's satisfaction) | up to two years | 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 |
Countries
Russia
Outcome results
None listed