Breast Cancer
Conditions
Keywords
Ribociclib, Endocrine therapy, Metastasis, Progression-free survival
Brief summary
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC). This study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Women ≥18 years old diagnosed with HR+ and HER2- aBC who received at least one dose of ribociclib in combination with ET following the approved indication, with at least one follow-up visit after diagnosis or death due to any cause.
Exclusion criteria
• Patients with prior/current enrollment in an interventional clinical trial for aBC/metastatic breast cancer and those who had received another cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Progression-free Survival (rwPFS) for the Entire Patient Group | Up to approximately 42 months | rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause. |
| rwPFS by Line of Therapy for the Entire Patient Group | Up to approximately 42 months | rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause. |
| Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group | Up to approximately 42 months | Clinical response categories included complete response, any response (other than complete response), no response, and any progression. |
| Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group | Up to approximately 42 months | Clinical response categories included complete response, any response (other than complete response), no response, and any progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up | Up to approximately 42 months | Clinical response categories included complete response, any response (other than complete response), no response, and any progression. |
| Number of Patients With Adverse Events | Up to approximately 42 months | — |
| Number of Adverse Events | Up to approximately 42 months | — |
| Number of Adverse Events by Severity | Up to approximately 42 months | — |
| Number of Patients who Discontinued Treatment by Reason for Discontinuation | Up to approximately 42 months | — |
| Number of Patients by Adverse Event That Led to Dose Discontinuation | Up to approximately 42 months | — |
| Number of Patients by Adverse Event That Led to Dose Reduction | Up to approximately 42 months | — |
| Number of Patients by Adverse Event That Led to Dose Interruptions | Up to approximately 42 months | — |
| rwPFS for Patients With at Least 6 Months of Follow-up | Up to approximately 42 months | rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause. |
| rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up | Up to approximately 42 months | rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause. |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed