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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribociclib Group | Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated with ribociclib in combination with ET. |
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| Measure | Description | Time Frame |
|---|---|---|
| Real-world Progression-free Survival (rwPFS) for the Entire Patient Group | 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. | Up to approximately 42 months |
| rwPFS by Line of Therapy for the Entire Patient Group | 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. | Up to approximately 42 months |
| Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group | Clinical response categories included complete response, any response (other than complete response), no response, and any progression. | Up to approximately 42 months |
| Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group | Clinical response categories included complete response, any response (other than complete response), no response, and any progression. | Up to approximately 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| rwPFS for Patients With at Least 6 Months of Follow-up | 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. | Up to approximately 42 months |
| rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up |
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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.
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This study included HR+/HER2- aBC patients who received ribociclib in combination with ET in India.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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. |
| Up to approximately 42 months |
| Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up | Clinical response categories included complete response, any response (other than complete response), no response, and any progression. | Up to approximately 42 months |
| 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 Interruptions | Up to approximately 42 months |
| Number of Patients by Adverse Event That Led to Dose Reduction | Up to approximately 42 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |