Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Greater than equal to 18 years old women 2. HR+ve and HER2-ve aBC diagnosis 3. Received ribociclib plus ET in line with the approved indication with at least one follow-up visit after diagnosis, or death due to any cause
Exclusion criteria
Exclusion criteria: 1. Any patient with prior/current enrollment in an interventional clinical trial for aBC/metastatic BC 2. Patient who has received another CDK4/6 inhibitor in any setting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate median real-world progression free survival (rwPFS) in Indian women with HR+ve, HER2-ve aBC receiving at least one dose of ribociclib by line of therapy, i.e., first line, second line, and subsequent linesTimepoint: 1. From Baseline to every follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate median real- world progression-free survival (rwPFS) in Indian women with HR positive, HER2 negative aBC by line of therapy receiving ribociclib with at least 6 months of follow-up 2. To evaluate safety and tolerability of ribociclib in Indian women with HR positive, HER2 negative aBC by the line of therapy receiving at least one dose of ribociclibTimepoint: 1. From Baseline to every follow-up visit 2. From Baseline to every follow-up visit | — |
Countries
India
Contacts
Public ContactKamal Panwar
Novartis Healthcare Private Limited
Outcome results
None listed