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.
Study Type
OBSERVATIONAL
Enrollment
335
Novartis
East Hanover, New Jersey, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 42 months
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.
Time frame: Up to approximately 42 months
rwPFS by Line of Therapy 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.
Time frame: 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.
Time frame: Up to approximately 42 months
Number of Patients With Adverse Events
Time frame: Up to approximately 42 months
Number of Adverse Events
Time frame: Up to approximately 42 months
Number of Adverse Events by Severity
Time frame: Up to approximately 42 months
Number of Patients who Discontinued Treatment by Reason for Discontinuation
Time frame: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Discontinuation
Time frame: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Interruptions
Time frame: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Reduction
Time frame: Up to approximately 42 months
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