Observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year.
The study was conducted in 11 Brazilian sites specialized in the treatment of this condition. The study data were collected from the review of medical records by the Investigator (or designated). The sites must have had adequate medical records to ensure robust medical record review. Therefore, a feasibility assessment was carried out at potential site prior to the study implementation to assess the adequacy of medical records and the data routinely available.
Study Type
OBSERVATIONAL
Enrollment
76
Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Proportion of patients alive and progression-free from disease at 1 year
The purpose was to evaluate the effectiveness of first-line ribociclib in combination with non-steroidal aromatase inhibitors in a Brazilian female population diagnosed with HR+/HER2- locally advanced or metastatic BC. Effectiveness was measured by the proportion of patients alive and free of disease progression at 1 year.
Time frame: 1 year post-treatment
Proportion of patients alive and progression-free from disease at 6 months
The purpose was to evaluate the effectiveness of first-line ribociclib in combination with non-steroidal aromatase inhibitors in a Brazilian female population diagnosed with HR+/HER2- locally advanced or metastatic BC. Effectiveness was measured by the proportion of patients alive and free of disease progression at 6 months post-treatment.
Time frame: 6 months post-treatment
Proportion of patients who had disease progression at 6 months
The purpose was to evaluate the proportion of patients who had disease progression at 6 months.
Time frame: 6 months post-treatment
Proportion of patients who had disease progression at 1 year
The purpose was to evaluate the proportion of patients who had disease progression at 1 year.
Time frame: 1 year post-treatment
Proportion of patients who died at 6 months
The purpose was to evaluate the proportion of patients who died at 6 months.
Time frame: 6 months post-treatment
Proportion of patients who died at 1 year
The purpose was to evaluate the proportion of patients who died at 1 year.
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Time frame: 1 year post-treatment
Proportion and cause of patients who reduced a treatment dose at 6 months
Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)
Time frame: 6 months post-treatment
Proportion and cause of patients who reduced a treatment dose at 1 year
Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)
Time frame: 1 year post-treatment
Frequency of dose interruption and cause, per patient, at 1 year
The purpose was to evaluate frequency of dose interruption and cause, per patient, at 1 year.
Time frame: 1 year post-treatment
Adverse Event frequency and classification of the severity degree
Frequency and classification of the degree of severity of the following adverse events of interest: neutropenia, febrile neutropenia, increased QT interval (\> 60 ms,\> 480ms ≤ 500 ms, and\> 500 ms), AST/ALT elevation three times greater than upper limit. In relation to the adverse events of interest, they were classified regarding the severity, graded from 1 to 4, corresponding to mild, moderate, severe and life-threatening, or as described in the medical record.
Time frame: throughout the study, approximately 1 year
Pattern of the treatment of AE of interest at 6 months
Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.
Time frame: 6 months post-treatment
Pattern of the treatment of AE of interest at 12 months
Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.
Time frame: 12 months post-treatment