Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer
- Registration Number
- NCT05569187
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ribociclib in combination with non-steroidal aromatase inhibitors Ribociclib Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year
- Primary Outcome Measures
Name Time Method Proportion of patients alive and progression-free from disease at 1 year 1 year post-treatment 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.
- Secondary Outcome Measures
Name Time Method Pattern of the treatment of AE of interest at 12 months 12 months post-treatment Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.
Frequency of dose interruption and cause, per patient, at 1 year 1 year post-treatment The purpose was to evaluate frequency of dose interruption and cause, per patient, at 1 year.
Adverse Event frequency and classification of the severity degree throughout the study, approximately 1 year 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.
Pattern of the treatment of AE of interest at 6 months 6 months post-treatment Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.
Proportion of patients alive and progression-free from disease at 6 months 6 months post-treatment 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.
Proportion of patients who had disease progression at 6 months 6 months post-treatment The purpose was to evaluate the proportion of patients who had disease progression at 6 months.
Proportion of patients who had disease progression at 1 year 1 year post-treatment The purpose was to evaluate the proportion of patients who had disease progression at 1 year.
Proportion of patients who died at 6 months 6 months post-treatment The purpose was to evaluate the proportion of patients who died at 6 months.
Proportion of patients who died at 1 year 1 year post-treatment The purpose was to evaluate the proportion of patients who died at 1 year.
Proportion and cause of patients who reduced a treatment dose at 6 months 6 months post-treatment Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)
Proportion and cause of patients who reduced a treatment dose at 1 year 1 year post-treatment Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)
Trial Locations
- Locations (1)
Novartis Investigative Site
🇧🇷Sao Paulo, SP, Brazil